P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged Adults: Acceptability and Feasibility of a Sleep Intervention
Phase: NA
Conditions: Metabolic Syndrome
Sponsor: NYU Langone Health

 
 
Official Title: 
P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged 
Adults: Acceptability and Feasibility of a Sleep Intervention   
NCT Number: 
NCT03596983 
Study Number: 
18-00707 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
9/29/2022 
 
 

 
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This material is the property of the NYU School of Medicine and Langone Medical Center. Do not disclose or use except as 
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Page i 
 
P20 Extending Sleep to Reverse the Metabolic Syndrome in Middle- 
Aged Adults: Acceptability and Feasibility of a Sleep Intervention 
A single site pilot study to determine the acceptability and feasibility of a twelve-week sleep extension 
intervention, self-management for adequate sleep intervention (SASI), in community-dwelling, middle- aged 
adults with the metabolic syndrome. 
Principal Investigator: 
Susan Kohl Malone 
NYU Rory Meyers College of Nursing 433 
First Avenue, New York, NY 10010  
sm7760@nyu.edu 732-693-8081 
Additional  
Investigators: 
Azizi Seixas 
NYU School of Medicine, Department of Population Health  
227 East 30th Street, New York, NY 10010 
azizi.seixas@nyumc.org 646-501-2672 
Victoria Vaughan Dickson 
NYU Rory Meyers College of Nursing 433 
First Avenue, New York, NY 10010 
vdickson@nyu.edu 212-992-9426 
Gail Melkus, PhD, RN, 
NYU Rory Meyers College of Nursing 
433 1St Avenue, New York, NY 10010 
gail.melkus@nyu.edu 212-992-7665 
Girardin Jean Louis 
NYU School of Medicine, Department of Population Health 
227 East 30th Street, New York, NY 10010 
Girardin.Jean-Louis@nyumc.org 
646-501-2623 
Gary Yu, PhD 
NYU Rory Meyers College of Nursing 433 
First Avenue, New York, NY 10010 
Gy8@nyu.edu 
212-998-5486 
 
Bradley Aouizerat, PhD 
Bluestone Center for Clinical Research 
345 E. 24th Street, Room 1024S, New York, NY 10010 
Bea4@nyu.edu 
212-998-9167 
NYULMC Study Number: 
18-00707 
Funding Sponsor: 
National Institutes of Health 
National Institute of Nursing Research  
1P20NR018075-01 
ClinicalTrials.gov 
Include the National Clinical Trial (NCT) Number assigned once the 
trial is registered on the ClinicalTrials.gov.  NCT03596983 

Study Number: 18-00707 
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Version Date: February  19, 2021 
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authorized in writing by the study sponsor Behavioral Intervention Template Version: 5 MAY 2017 
Initial version: June 1, 2018 
Amended: 
Amended: 
Statement of Compliance 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), any other applicable US government research regulations, and 
institutional research policies and procedures. The Principal Investigator will assure that no deviation from, 
or changes to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
 

Study Number: 18-00707 
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Table of Contents 
EXTENDING SLEEP TO REVERSE METABOLIC SYNDROME IN MIDDLE-AGED ADULTS:  
ACCEPTABILITY AND FEASIBILITY OF A SLEEP INTERVENTION.........................................................I 
PROTOCOL SUMMARY..............................................................................................................................1 
SCHEMATIC OF STUDY DESIGN...............................................................................................................3 
KEY ROLES.................................................................................................................................................4 
1 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE........................7 
1.1 BACKGROUND INFORMATION AND RELEVANT LITERATURE ................................................................7 
1.2 RATIONALE....................................................................................................................................8 1.3 
POTENTIAL RISKS & BENEFITS........................................................................................................9 
 
1.3.1 
Known Potential Risks.............................................................................................................9 
 
1.3.2 
Known Potential Benefits ......................................................................................................10 
2 
OBJECTIVES AND PURPOSE.........................................................................................................10 
2.1 PRIMARY 
OBJECTIVE....................................................................................................................11 
2.2 SECONDARY OBJECTIVES (IF APPLICABLE).....................................................................................11 
3 
STUDY DESIGN AND ENDPOINTS..................................................................................................11 
3.1 DESCRIPTION OF STUDY DESIGN ..................................................................................................11 
3.2 STUDY ENDPOINTS ......................................................................................................................11 
 
3.2.1 
Primary Study Endpoints.......................................................................................................11 
 
3.2.2 
Secondary Study Endpoints..................................................................................................11 
 
3.2.3 
Exploratory Endpoints...........................................................................................................12 
4 
STUDY ENROLLMENT AND WITHDRAWAL ..................................................................................12 
4.1 INCLUSION 
CRITERIA....................................................................................................................12 
4.2 EXCLUSION 
CRITERIA...................................................................................................................12 
4.3 VULNERABLE 
SUBJECTS...............................................................................................................13 
4.4 STRATEGIES FOR RECRUITMENT AND RETENTION ..........................................................................13 
 
4.4.1 
Electronically-posted flyers ...................................................................................................13 
 
4.4.2 
Advertising in the community................................................................................................13 
 
4.4.3 
Posted/distributed flyers........................................................................................................13 
 
4.4.4 
NYU Langone Health recruitment .........................................................................................14 
 
4.4.5 
Past study participants..........................................................................................................14 
 
4.4.6 
Use of DataCore/Epic Information for Recruitment Purposes...............................................14 
 
4.4.7 
Research Match....................................................................................................................14 
 
4.5 
DURATION OF STUDY PARTICIPATION ............................................................................................15 
 
4.5.1 
Reasons for Withdrawal or Termination................................................................................15 
 
4.5.2 
Handling of Participant Withdrawals or Termination..............................................................15 
 
4.5.3 
Premature Termination or Suspension of Study....................................................................15 
5 
BEHAVIORAL/SOCIAL INTERVENTION.........................................................................................15 
 
5.1 
STUDY BEHAVIORAL OR SOCIAL INTERVENTION(S) DESCRIPTION ....................................................16 
 
5.1.1 
Administration of Intervention................................................................................................16 
 
5.1.2 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity ....................16 
 
5.1.3 
Assessment of Subject Compliance with Study Intervention.................................................16 
6 
STUDY PROCEDURES AND SCHEDULE .......................................................................................16 

Study Number: 18-00707 
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6.1 
STUDY PROCEDURES/EVALUATIONS .............................................................................................16 
 
6.1.1 
Study Specific Procedures....................................................................................................16 
 
6.1.2 
Standard of Care Study Procedures .....................................................................................19 
 
6.2 
LABORATORY PROCEDURES/EVALUATIONS ...................................................................................19 
 
6.2.1 
Clinical Laboratory Evaluations.............................................................................................19 
 
6.2.2 
Other Assays or Procedures .................................................................................................19 
 
6.2.3 
Specimen Preparation, Handling, and Storage.....................................................................19 
 
6.2.4 
Specimen Shipment..............................................................................................................20 
 
6.3 
STUDY SCHEDULE .......................................................................................................................20 
 
6.3.1 
Screening..............................................................................................................................19 
 
6.3.2 
Enrollment/Baseline ..............................................................................................................19 
 
6.3.3 
Intermediate Visits.................................................................................................................20 
 
6.3.4 
Final Study Visit (within 3 weeks of completing SASI)....................................................22 
 
6.3.5 
Withdrawal Visit.....................................................................................................................22 
 
6.3.6 
Unscheduled Visit .................................................................................................................22 
 
6.4 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES....................................................23 
7 
ASSESSMENT OF SAFETY .............................................................................................................23 
 
7.1 
SPECIFICATION OF SAFETY PARAMETERS......................................................................................23 
 
7.1.1 
Definition of Adverse Events (AE).........................................................................................23 
 
7.1.2 
Definition of Serious Adverse Events (SAE).........................................................................23 
 
7.1.3 
Definition of Unanticipated Problems (UP)............................................................................23 
 
7.2 
CLASSIFICATION OF AN ADVERSE EVENT.......................................................................................24 
 
7.2.1 
Severity of Event...................................................................................................................24 
 
7.2.2 
Relationship to Study Intervention ........................................................................................24 
 
7.2.3 
Expectedness........................................................................................................................24 
 
7.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP ....................................24 
 
7.4 
REPORTING PROCEDURES – NOTIFYING THE IRB..........................................................................25 
 
7.4.1 
Adverse Event Reporting......................................................................................................25 
7.4.2 Serious Adverse Event Reporting.........................................................................................25 
7.4.3 Unanticipated Problem Reporting.........................................................................................25 
 
7.4.4 
Reporting of Pregnancy ........................................................................................................26 
7.5 REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR ......................................................26 
7.6 REPORTING PROCEDURES – PARTICIPATING INVESTIGATORS.........................................................27 
7.7 STUDY HALTING RULES................................................................................................................27 
7.8 SAFETY OVERSIGHT.....................................................................................................................27 
8 
CLINICAL MONITORING..................................................................................................................29 
9 
STATISTICAL CONSIDERATIONS..................................................................................................29 
9.1 STATISTICAL AND ANALYTICAL PLANS ...........................................................................................29 
9.2 STATISTICAL 
HYPOTHESES...........................................................................................................30 
9.3 ANALYSIS DATASETS ...................................................................................................................30 
9.4 DESCRIPTION OF STATISTICAL METHODS ......................................................................................30 
 
9.4.1 
General Approach.............................................................................................................30 
 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s)....................................................................30 
 
9.4.3 
Analysis of the Secondary Endpoint(s).............................................................................31 
 
9.4.4 
Safety Analyses................................................................................................................31 
 
9.4.5 
Adherence and Retention Analyses .................................................................................31 
 
9.4.6 
Baseline Descriptive Statistics..........................................................................................31 
 
9.4.7 
Planned Interim Analysis ..................................................................................................31 

Study Number: 18-00707 
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9.4.8 
Additional Sub-Group Analyses........................................................................................32 
 
9.4.9 
Multiple Comparison/Multiplicity .......................................................................................32 
 
9.4.10 
Tabulation of Individual Response Data...........................................................................32 
 
9.4.11 
Exploratory Analyses........................................................................................................32 
9.5 SAMPLE SIZE...............................................................................................................................32 9.6 
MEASURES TO MINIMIZE BIAS.......................................................................................................32 
 
9.6.1 
Enrollment/Randomization/Masking Procedures..............................................................32 
 
9.6.2 
Evaluation of Success of Blinding.....................................................................................32 
9.6.3 Breaking the Study Blind/Participant Code.......................................................................32 10 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................................32 11
 
QUALITY 
ASSURANCE 
AND 
QUALITY 
CONTROL.......................................................................33 
12 
ETHICS/PROTECTION OF HUMAN SUBJECTS.............................................................................33 
12.1 ETHICAL 
STANDARD.....................................................................................................................33 
12.2 INSTITUTIONAL REVIEW BOARD.....................................................................................................33 
12.3 INFORMED CONSENT PROCESS ....................................................................................................34 
 
12.3.1 
Consent/Assent and Other Informational Documents Provided to Participants................34 
 
12.3.2 
Consent Procedures and Documentation.........................................................................34 
 
12.4 
PARTICIPANT AND DATA CONFIDENTIALITY ....................................................................................35 
 
12.4.1 
Research Use of Stored Human Samples, Specimens, or Data ......................................35 
 
12.5 
FUTURE USE OF STORED SPECIMENS...........................................................................................36 
13 
DATA HANDLING AND RECORD KEEPING...................................................................................37 
13.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES..............................................................37 
13.2 STUDY RECORDS RETENTION.......................................................................................................37 
13.3 PROTOCOL DEVIATIONS ...............................................................................................................37 
13.4 PUBLICATION AND DATA SHARING POLICY.....................................................................................38 
14 
STUDY FINANCES............................................................................................................................38 
14.1 FUNDING SOURCE .......................................................................................................................38 
14.2 COSTS TO THE PARTICIPANT ........................................................................................................39 
14.3 PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................39 
15 
STUDY ADMINISTRATION...............................................................................................................39 
 
15.1 
STUDY LEADERSHIP.....................................................................................................................39 
16 
CONFLICT OF INTEREST POLICY..................................................................................................39 
17 
REFERENCES...................................................................................................................................40 
18 
ATTACHMENTS................................................................................................................................43 
List of Abbreviations 
AE 
Adverse Event/Adverse Experience 
AHI 
Apnea hypopnea index 
ASA24 
NCI Automated Self-Administered 24-hour diet recall 
AUDIT 
Alcohol Use Disorders Identification Test 
CAT 
Computer Adaptive Testing 

Study Number: 18-00707 
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CBTI 
Cognitive Behavioral Therapy for Insomnia 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CRC 
Clinical Research Center 
CRF 
Case Report Form 
CBRD 
Center for Biospecimen Research and Development 
CTSI 
Clinical and Translational Science Institute 
EMR 
Electronic Medical Record 
FBG 
Fasting Blood Glucose 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
HDL-c 
High density lipoprotein cholesterol 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
ISI 
Insomnia Severity Index 
MetS 
Metabolic Syndrome 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
NINR 
National Institute of Nursing Research 
NYU 
New York University 
OHRP 
Office for Human Research Protections 
OSA 
Obstructive sleep apnea 
PI 
Principal Investigator 
QA 
Quality Assurance 
 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
QC 
Quality Control 
RA 
research assistant 
REDCap 
Research Electronic Data Capture 

Study Number: 18-00707 
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SAE 
Serious Adverse Event/Serious Adverse Experience 
SASI 
Self-management for Adequate Sleep Intervention 
SDOH 
Social Determinants of Health 
SOP 
Standard Operating Procedure 
TG 
Triglycerides 

 
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Study Number: 18-00707  
page 1 
Version Number: September 27, 2019 
Protocol Summary 
Title 
P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged 
Adults: Acceptability and Feasibility of a Sleep Intervention 
Short Title 
P20 Malone Pilot 
Brief Summary 
This pilot study will test the acceptability and feasibility of a sleep extension 
intervention in community-dwelling, short-sleeping, racially/ethnically diverse 
middle-aged adults with MetS. Baseline sleep habits will be assessed and 
used to guide individualized strategies to extend sleep. A 1-group pretest-
posttest study design will test the efficacy of this 18-week study (2 weeks of 
baseline data collection, 1 week of study intervention planning, 12 weeks of 
sleep intervention delivery, final follow up 3 weeks after last day of the 12-
week intervention) on sleep duration, MetS risk behaviors (reduced physical 
activity, increased sedentary behavior, poor diet quality), symptoms 
associated with MetS risk behaviors (poor affective well-being, fatigue), and 
self-regulation. Socio-ecological barriers and facilitators to the intervention 
will be identified using a quantitative and qualitative approach. 
Phase 
Pilot study 
Objectives 
Primary Objective: Test the feasibility and acceptability of a self- 
management for adequate sleep intervention (SASI) in community- 
dwelling, short-sleeping, middle-aged adults with MetS. 
Secondary Objective: Assess the preliminary efficacy of SASI on sleep 
duration, MetS risk behaviors (physical activity, sedentary behavior, diet 
quality), symptoms associated with MetS risk behaviors (affective well-
being, fatigue) and self-regulation. 
Exploratory Objective: Explore the perceived barriers and facilitators of SASI 
(e.g., socio-ecological factors) barriers and facilitators of SASI (e.g., socio-
ecological factors). 
Methodology 
1-group pre-test and post-test pilot study 
Endpoint 
Primary Endpoints: 1) Acceptability (pre-intervention and post- intervention, 
2) Feasibility (recruitment rate, retention rate, protocol adherence rate). 
Secondary Endpoints: 1) sleep duration, 2) physical symptoms, 3) physical 
activity, 4) sedentary behavior, 5) diet quality, 6) affective well– being, 7) 
self-regulation. 
Study Duration 
3 years 
Participant Duration 
18 weeks 
Duration of behavioral 
intervention 
12 weeks 
Population 
Participants will be male and female, 35-60 year old, short-sleeping adults 
from diverse racial/ethnic groups with the Metabolic Syndrome in the greater 
New York City area. 
Study Sites 
NYU Langone Health 
NYU Rory Meyers College of Nursing 

 Study Number: 18-00707 
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Drug/Device Template Version: 13 JUN 2016 
 
Number of participants 
We will screen approximately 220 individuals for a final sample of N= 60 
participants. Of these 220 participants, we anticipate that 65% will become 
ineligible through the multi-stage screening process and 20% will be lost to 
attrition during the intervention leaving 60 participants with evaluable data. 
Description of Study 
Intervention/Procedure 
SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI). Like 
CBTI, SASI extends sleep based on sleep efficiency (the proportion of time 
spent sleeping during a sleep episode). Bedtimes and wake times will be 
prescribed each week for each participant and allow for gradual increases in 
sleep opportunity. Bedtimes will be set 15 minutes earlier each week 
provided sleep efficiency remains >90%. Earlier bedtimes will extend sleep 
duration by increasing the opportunity for sleep. Wake times will not be 
changed because wake times are often determined by external demands, 
such as work schedules. 
Reference Therapy 
Not applicable. 
Key Procedures 
Surveys, patient reported outcomes, anthropometric measurements, blood 
pressure measurement, daily sleep diaries, wrist accelerometry, blood draw 
(3 ml CTSI visit 1), open-ended interview. 
Statistical Analysis 
Primary endpoints: 1) Acceptability based on the percentage of pre and post 
intervention acceptability surveys with total scores < 21  
(unacceptable), 21 (neutral), greater than 21 (acceptable). 2) Feasibility will 
be based on recruitment, retention, and study protocol adherence rates. 
 
 
Bellevue Hospital 462 1st Avenue, New York, NY 10016 in C/D Building, 
4th Floor New York, NY. 

 Study Number: 18-00707 
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Schematic of Study Design 
Screening/  
CTSI Visit 1 
• Research Assistants will identify eligible participants through EPIC, Datacore, and other  
recruitment strategies. N= 220 individuals will be screened for inclusion / exclusion criteria  
using a multi-stage screening process that includes 1) a telephone screen, 2) a CTSI visit to  
obtain informed consent, complete screening surveys, and obtain anthropometric and blood  
pressure measurements, 3) a 2-week baseline data collection to objectively confirm short  
sleep and establish treatment of OSA (at home). 
Baseline data  
collection  
at home ) 
( 
Objectively screen for short sleep : Wrist accelerometry and fitbit 24/7 for 14 days, daily sleep diaries.  
• 
Objectively establish OSA treatment : Wear pulse oximeter for 1-night.  
:  
Complete baseline surveys 
Acceptability survey, Composite Scale of Morningness, Economic Vulnerability Survey, Family  
Assessment: General Functioning Scale, Sleeping Environment Survey, 36-item Short Form Health  
Survey (SF -36) version 1, ASA24, Demographics-Social Determinants of Health (SDOH): Alcohol use  
( AUDIT C), Demographics- SDOH: Alcohol Use, Index of Self- regulation, SAFTEE Questionnaire, PROMIS 
Depression 6a.  Other  weekly surveys : Epworth Sleepiness Scale, PROMIS Fatigue 6a – morning PROMIS 
Fatigue 6a – evening, 
Intervention  
( at home ) 
• Sleep diaries (daily), fitbit 24/7, Phone/videoconference calls (weekly with study  
team), Epworth Sleepiness Scale (weekly), PROMIS Fatigue 6a- morning (weekly)–  
PROMIS Fatigue 6a- evening (weekly). 
Last 2 weeks of  
intervention  
) 
( at home 
• Sleep diaries (daily), Phone calls (weekly with study team), Wrist accelerometry and  
fitbit 24/7 for 14 days, 36-item Short Form Health Survey (SF-36) version 1, ASA24,  
Demographics- SDOH: Alcohol use (AUDIT C), Demographics- SDOH: Alcohol Use,  
Index of Self-regulation, SAFTEE Questionnaire; PROMIS Depression 6a. Other weekly  
surveys: PROMIS Fatigue 6a– morning, PROMIS Fatigue 6a–evening, Epworth  
Sleepiness Scale. 
Final Visit  
( at home ) 
• Acceptability survey. 
• Open-ended Interview . 

 Study Number: 18-00707 
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Key Roles 
Susan Kohl Malone, PhD, RN,  
Senior Research Scientist 
NYU Rory Meyers College of Nursing  
433 1St Avenue 
New York, New York 10010  
732-693-8081 sm7760@nyu.edu 
Principal Investigator: Dr. Malone will direct and oversee all aspects of the pilot study, ensuring that study 
procedures are implemented and maintained for the enrollment of participants, form development, collection 
of data, data management, and budget maintenance. She will have primary responsibility for oversight of 
data analysis, preparation of manuscripts, and the submission of annual and final reports. 
Azizi Seixas, PhD, Assistant Professor 
NYU School of Medicine Department of Population  
Health 270 East 30th Street 
New York, New York 10010  
646-501-2672 azizi.seixas@nyumc.org 
Co-investigator: Dr. Seixas is well experienced leading funded projects related to sleep, cardio-metabolic 
health and racial/ethnic disparities. Dr. Seixas has worked as a project manager on several NIH-funded sleep-
related studies including a NIMHD-funded R01 study on sleep obstructive sleep apnea among Blacks and as 
a principal investigator on a NIH-funded K01 award investigating the relationship between insufficient sleep 
and cardiovascular disease markers between Blacks and Whites. Dr. Seixas’ expertise will also be brought to 
bear on recruiting community participants and identifying barriers to extending sleep across diverse 
subgroups. Dr. Seixas will contribute to the dissemination of study findings. 
Victoria Vaughan Dickson, PhD, RN, Associate Professor, 
NYU Rory Meyers College of Nursing  
433 1St Avenue 
New York, New York 10010  
212-992-9426 vdickson@nyu.edu 
Co-investigator: Dr. Dickson is an Associate Professor in the NYU Rory Meyers College of Nursing, Director 
of the Pless Center for Nursing Research, program director of the NYU Meyers NIOSH-funded T42 Program 
in Occupational and Environmental Health Nursing, and co-director of the NIH-funded NYU School of Medicine 
CTSA Scholars Program. Dr. Dickson’s work has led to an improved understanding of the socio- cultural 
influences of self-care among women and racial/ethnic minority groups and the development of innovative 
theory based interventions. This expertise will be brought to bear on our proposed CTSI pilot project. Dr. 
Dickson is also an international expert in qualitative research techniques and mixed methods research. She 
will provide expertise for the qualitative design and analysis where we will identify barriers and facilitators to 
the sleep intervention. Dr. Dickson will play a critical role in identifying and recruiting potential participants. The 
overarching goal of his research is to address patient- level, provider-level, and system-level barriers hindering 
adoption of healthful practices. 
Girardin Jean-Louis 
Professor of Population Health and Psychiatry  
Center for Healthful Behavior Change  
Department of Population Health 
New York University School of Medicine 
227 East 30th St, 6th Floor  
New York, NY 10016 
646-501-2623 
Girardin.Jean-Louis@nyumc.org 

 Study Number: 18-00707 
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Co-investigator: Dr. Jean Louis is Professor of Population Health and Psychiatry at NYU Langone Health. He is 
Director of the NHLBI-funded PRIDE Summer Institute on Behavioral Medicine and Sleep Disorders Training 
Institute and Director of the T32 Program on Translational Behavioral Cardiovascular Health Research. He 
served for three years on the NHLBI’s Sleep Disorders Research Advisory Board, and for four years as a member 
of the Cancer, Heart, and Sleep Epidemiology (CHSB) study section, and the NHLBI Special Emphasis 
Panel/Scientific Review Group. As PI for several past studies, Dr. Jean Louis will play a critical role in recruiting 
potential participants and provide expertise in the proposed sleep intervention. 
Gary Yu, PhD 
NYU Rory Meyers College of Nursing 
433 1St Avenue 
New York, New York 10010  
212 998-5486 Gy9@nyu.edu 
Biostatistician: Dr. Yu is a biostatistician trained at Columbia’s Mailman School of Public Health. His dissertation 
involved creating a new dimensional-informative mixture model (DIMM) [NIH/NHLBI R01HL111195], a model-
based clustering technique to create endophenotypes of major chronic conditions (MCC) (i.e. pain, fatigue, 
depression, CVD) under conditions of severe disease heterogeneity in the clinical diagnosis.  Dr. Yu has applied 
a variety of advanced analysis approaches to complex longitudinal data including multiple imputation for missing 
data, structural equation modeling, generalized estimating equations, and linear and generalized linear mixed 
models. His expertise as a biostatistician will be brought to bear on the quantitative analyses of the proposed 
study aims and complement the qualitative analyses exploring the individual, family, and community factors 
influencing sleep extension. His work addressing barriers to racial/ethnic minorities for participating in research 
studies will inform the study design and analysis. 
Bradley Aouizerat, PhD 
Bluestone Center for Clinical Research 
345 E. 24th Street, Room 1024S, New York, NY 10010 
New York, New York 10010  
212 998-9167 Bea4@nyu.edu 
Fay Wright PhD, APRN-BC  
Assistant Professor 
NYU Rory Meyers College of Nursing  
433 1St Avenue 
New York, New York 10010  
914-672-4231 fay.wright@nyu.edu 
Key Collaborator: Dr. Wright is Assistant Professor at the NYU Rory Meyers College of Nursing. Her expertise 
in fatigue research will be brought to bear on the analyses of these data. Dr. Wright will also assist in identifying 
and recruiting potential participants. 
Gail Melkus, PhD, RN, Professor & Associate Dean for Research  
NYU Rory Meyers College of Nursing 
433 1St Avenue 
New York, New York 10010  
212-992-7665 gail.melkus@nyu.edu 
Key Collaborator: Dr. Melkus is the Florence and William Downs Professor in Nursing Research, Associate 
Dean for Research, and Director of the Muriel and Virginia Pless Center for Nursing Research. Her expertise 
in conducting behavioral intervention research and serving as a career development mentor to many rising 
early-career scientists will benefit Dr. Malone in the conduct of this pilot study. 
Laura Prescott 
P20 Program Manager 
NYU Rory Meyers College of Nursing  
433 1St Avenue 

 Study Number: 18-00707 
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New York, New York 10010  
212 992 5954 lp83@nyu.edu 
Agnes Wong, MA 
Pilot Project Coordinator 
NYU Rory Meyers College of Nursing  
433 1St Avenue 
New York, New York 10010 aw813@nyu.edu 
Franklin Zizi 
Assistant Research Scientist 
NYU Rory Meyers College of Nursing Franklin.Zizi@nyulangone.org 
Amy Warner, MSN, FNP-C  
Research Assistant 
NYU Rory Meyers College of Nursing alw613@nyu.edu 
Lauren Ghazal, MS, FNP-BC  
Research  Assistant 
NYU Rory Meyers College of Nursing lvg220@nyu.edu 
Nicole B. Perez, MSN, ARNP, PMHNP-BC 
Research Assistant 
NYU Rory Meyers College of Nursing nbp273@nyu.edu 
 
Clinical and Translational Science Institute, Bellevue Hospital 
462 1st Avenue, New York, NY 10016 in C/D Building, 4th Floor New York, NY 
ctsi@nyumc.org 
One outpatient visit will take place at this site the remainder of the study will take place in the home environment 

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1 Introduction, Background Information and Scientific Rationale 
1.1 
Background Information and Relevant Literature 
Name and description of the study intervention. The Self-management for Adequate Sleep Intervention (SASI) 
is a 12-week self-management for adequate sleep intervention (SASI) that extends sleep gradually based on 
individual responses to the intervention. Participants will be enrolled in the study for 18 weeks because we 
will be collecting baseline sleep data during weeks 1 and 2, confirming eligibility based on objectively 
measured sleep and personalizing the intervention during week 3, delivering SASI weeks 4-15, and 
completing the last study visit within 3 weeks of the last day of the intervention. SASI is based on Cognitive 
Behavioral Therapy for Insomnia (CBTI). Like CBTI, SASI extends sleep based on sleep efficiency (the 
proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each 
week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes 
earlier each week provided sleep efficiency remains >90%. Earlier bedtimes will extend sleep duration by 
increasing the opportunity for sleep. Wake times will not be changed because wake times are often 
determined by external demands, such as work schedules. 
Summary of relevant clinical research. Diet and exercise are the first line of treatment for effectively reducing 
the Metabolic Syndrome (MetS)1. However, disappointing outcomes are reported when diet and exercise 
programs are translated into less intense, more affordable community based programs. Less intense programs 
report only half the amount of weight loss achieved by more intense programs2. Moreover, only 50% of 
Americans with elevated glucose levels attempt modifying their diets and physical activity3. Poor participation 
rates suggest that diet and exercise are only effective for select, highly motivated individuals4. Extending sleep 
is an innovative approach to reducing MetS because it shifts the first line of treatment from diet and exercise 
alone to include sleep, a potentially modifiable, upstream factor for MetS. 
Discussion of important literature and data that are relevant to the trial and that provide background for the trial. 
Applicable clinical, epidemiological, or public health background or context of the study. Short sleep, defined as 
≤ 6 hours/night5, is strongly associated with MetS6, a cluster of risk factors that profoundly increases the risk for 
multiple chronic conditions such as type 2 diabetes7. The highest prevalence of short sleep (~30%) is reported 
by middle-aged adults (35-60 years old)8. Extending sleep in short sleepers without MetS improves behavioral 
and clinical risk factors, as it reduces hedonic food cravings9 and improves insulin sensitivity and blood 
pressure10,11. Average 24-hour systolic and diastolic blood pressures are reduced by 14mmHG and 8mmHG, 
respectively, following sleep extension11. Progress in extending sleep interventions to persons with MetS is 
limited by the absence of intervention studies in community- dwelling, racially/ethnically diverse, middle-aged 
adults with MetS. The extent to which this high risk, understudied group can extend sleep and the contextual 
factors influencing their ability to do so are not known. Also unknown is whether extending sleep improves 
symptoms, such as poor affective well-being and fatigue, that are associated with MetS risk behaviors12,13. 
Short sleep may directly impact MetS, a chronic inflammatory state14, by furthering inflammation.  
Elevated C-reactive protein has been found in habitual short sleepers15. Short sleep may also impact MetS 
through its effect on MetS risk behaviors16-18. Reduced physical activity, increased sedentary behavior, and 
unhealthy diets are associated with habitual short sleep19,20. Sleep deprivation symptoms, such as poor 
affective well-being and fatigue21, further increase MetS risk behaviors12,13. Finally, short sleep impairs 
executive functioning22, such as self-regulatory capacities that are important for adopting and sustaining 
healthy behaviors23. 
Importance of the study and any relevant treatment issues or controversies. Critical barriers exist to using sleep 
interventions to address MetS. First, laboratory findings may not translate to the context of people's real lives. 
Community-based interventions are needed to draw conclusions about the effects of sleep extension on MetS. 
For example, a 3-week community-based sleep restriction study reported increased insulin resistance after 1 
week, corroborating laboratory evidence24, but reduced insulin resistance during the remaining weeks25, 
contradicting laboratory evidence. This exemplifies a shortcoming of lab studies and the profound implications 
for treatment interventions. Second, racial/ethnic minorities are under-represented in extant sleep extension 
studies. Yet, Black adults are more likely to be short sleepers26 and are more vulnerable to the adverse effects 
of short sleep27. Third, socio-ecological factors at the individual (e.g., gender)28, microsystem (e.g., family 
support)29, and exosystem (neighborhood conditions)30  levels affect sleep. Yet, existing sleep extension 
studies10,11 have relied on generic approaches advising individuals to sleep more. These recommendations lack 

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the precision needed to be effective in diverse populations because they do not account for individual variability 
in lifestyle. Additionally, these recommendations do not address how to extend sleep. 
This proposed study is significant because it will determine the acceptability and feasibility of a sleep 
intervention in an understudied population: racially/ethnically diverse middle-aged adults with MetS. The 
preliminary evidence of the effectiveness of this intervention will translate laboratory evidence suggesting that 
sleep can improve metabolic health into a promising new treatment for individuals with MetS, a group at high 
risk for multiple chronic conditions in later life. The socio-ecological factors identified will contribute to targeting 
and tailoring future sleep interventions in high-risk, understudied groups. The preliminary data generated will 
be used to test this intervention in a fully powered randomized control trial. Without personalized strategies to 
reduce MetS severity in middle age, healthy aging will be thwarted by a higher and lengthier burden of 
multiple chronic conditions in later life. 
1.2 
Rationale 
State the problem or question under study (e.g., describe the disease and current limitations of knowledge or 
therapy). Include a statement of the hypothesis. Progress in extending sleep extension interventions to persons 
with MetS is limited by the absence of intervention studies in community- dwelling, racially/ethnically diverse, 
middle-aged adults with MetS. The extent to which racially/ethnically diverse middle-aged adults with MetS can 
extend sleep and the contextual factors influencing their ability to do so are not known. Also unknown is 
whether extending sleep improves symptoms, such as poor affective well-being and fatigue, that are 
associated with MetS risk behaviors12,13. In this study, we will: 1) 
Test the feasibility and acceptability of a 
self-management for adequate sleep intervention (SASI) in community-dwelling, short-sleeping, middle-aged 
adults with MetS. 
2) Assess the preliminary efficacy of SASI on sleep duration, MetS risk behaviors (physical activity, 
sedentary behavior, diet quality), symptoms associated with MetS risk behaviors (affective well-being, 
fatigue) and self- regulation. 
3) Explore the perceived barriers and facilitators of SASI (e.g., socio-ecologicalfactors). 
Justification for the method of administration, treatment regimen of the intervention, intervention periods, 
and selection of study population. The method of administration, SASI, is based on Cognitive Behavioral 
Therapy for Insomnia (CBTI). SASI differs from CBTI because the first step of sleep restriction prescribed 
by CBTI is not used in SASI. This is because the participants have already been verified as short- sleepers. 
However, SASI does employ CBTI’s gradual approach for increasing sleep time and applies it to short 
sleepers. CBTI has demonstrated effectiveness in improving sleep in persons with insomnia31,32. 
Increasing sleep duration gradually has also been demonstrated to sustain sleep quality. The 12- week 
intervention period of gradually increasing sleep duration by advancing bedtimes 15 minutes per week (or 
1 hour per month) will provide the time needed to increase sleep duration in habitual 5 hour sleepers to the 
recommended 7 to 8-hour sleep duration. Our preliminary data from an 8-week sleep extension intervention 
increased sleep duration up to 2 hours over 8 weeks using this approach (Grandner, unpublished data). 
Moreover, 12 weeks will provide preliminary data regarding adaptation to adequate sleep duration (7-8 
hours) and the effects of the sleep intervention on key biomarkers that may be missed by shorter 
intervention periods, such as improved triglyceride and HDL-c measures. The study population selected 
was middle-aged adults with MetS because short sleep has been associated with MetS. Plausible biological 
and behavioral pathways have been demonstrated 
and further support a relationship between MetS and short sleep10. Middle-aged adults were chosen for this 
pilot study because short sleep is more prevalent in middle-aged adults than other stages of adulthood12. 
Discuss known or potential problems associated with the control group chosen in light of the specific disease 
and therapies being studied. There is no control group. This is a one group pre-and post- intervention study 
design that will provide preliminary data for a fully powered R01 randomized controlled trial. 

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1.3 
Potential Risks & Benefits 
1.3.1 
Known Potential Risks 
This study involves no more than minimal risk, as defined by federal regulations, to research participants. The 
probability and magnitude of harm or discomfort anticipated for this research are not greater than what the 
population encounters in daily life or during the performance of physical or psychological examinations or tests. 
The only alternative to study participation is non-participation. Non-participation will in no way affect the 
potential participant’s medical care. 
Loss of confidentiality. To protect against loss of confidentiality all survey data and clinical assessment data 
will be entered directly into REDCap (Research Electronic Data Capture). REDCap is a secure, web-based 
application designed to support data capture and storage for research studies, providing 1) an intuitive 
interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) 
automated export procedures for seamless data downloads to common statistical packages; and 4) 
procedures for importing data from external sources. REDCap has been designed to allow for compliance 
with such standards as HIPAA, 21 CFR Part 11, and international standards. Also included are a built-in 
project calendar, a scheduling module, ad hoc reporting tools, and advanced features, such as branching 
logic, file uploading, and calculated fields. For further information about protecting against the risk of loss of 
confidentiality, please see Section 8.8  
Protection Participant Confidentiality. Audiotaped intervention sessions that will be used to ensure the quality of 
the intervention and judge treatment fidelity will be reviewed by Dr. Dickson and the PI and subsequently 
destroyed. 
Discomfort. To protect against discomfort associated with the accelerometer, participants will be instructed in 
person during their CTSI intake visit on the use of these devices. Participants will be given verbal as well as 
written, illustrated instructions for using the devices. Study team 24/7 contact information will also be provided 
to assist with troubleshooting. Participants may also remove the accelerometer and note this in their sleep 
diary.  
Sleep complaints associated with the sleep extension intervention will be protected against by carefully 
monitoring sleep efficiency throughout the study. Careful monitoring of sleep efficiency and excessive 
sleepiness will significantly reduce risk for insomnia and other negative outcomes. The treatment for insomnia 
on which SASI is based (Sleep Restriction Therapy) can produce sleepiness, especially in the initial weeks of 
treatment. The proposed intervention, though, does not begin with a curtailment of sleep opportunity, so these 
issues should not be present. Sleep will be extended gradually and on an individual basis using the results 
from the previous week’s sleep diary data. Participants diagnosed with an ARES score of greater than or 
equal to six suggesting OSA will be referred to the Sleep Disorders Center at NYU Langone Health for further 
evaluation and treatment. 
Blood drawing risks. The risk of blood specimen collection is within the routine of clinical care. To protect 
against potential risks associated with the blood draw such as dizziness, decreased alertness, and symptoms 
associated with low blood sugar, every effort will be made to schedule the CTSI appointment between 0800 
and 1000. A free light breakfast of cereal, juice, and muffins is provided by the CTSI to all research 
participants. Potential risks will also be minimized by using skilled and trained personnel to perform blood 
collection to minimize discomfort and potential for infection. Blood will be drawn following standard procedures. 
Standard techniques at the NYU CTSI will be used for analysis of the blood samples according to CLIA 
standards. Approximately 3 ml of blood will be drawn (as needed to objectively confirm MetS) during CTSI visit 
1. 
Inconvenience. To minimize the most likely risk of inconvenience, the following steps will be undertaken to 
reduce burden. Short forms of the surveys will be used wherever appropriate. 
Embarrassment. To minimize embarrassment that may be associated with survey questions and waist 
measurements, we have selected survey questions that have been established and used in previous research 
studies. Waist circumference is a routine measurement taken in health care settings for persons with MetS. To 
protect against embarrassment participants will be free to omit answers and or refuse waist measurements. 
Additionally, waists will be measured in a private exam room. Clinicians sensitive to emotional or physical 

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responses to these procedures will conduct these interviews and examinations. Participants who are 
psychologically distressed will be referred for appropriate treatment. 
Rationale for the necessity of exposing human participants to such risks. There is a critical need to develop 
personalized strategies to reverse MetS in middle-aged adults. Without such strategies to reduce MetS severity 
in middle age, healthy aging will be thwarted by a higher and lengthier burden of multiple chronic conditions in 
later life. 
Why the value of the information to be gained outweighs the risks involved. These data will provide a more 
complete understanding of the association between sleep and MetS. This study will determine the acceptability 
and effectiveness of extending sleep in a high-risk, understudied group: racially/ethnically diverse, short-
sleeping middle age adults with MetS. The socio-ecological factors identified will contribute to targeting and 
tailoring future sleep interventions in high risk, understudied groups. 
If risk is related to proposed procedures included in protocol, any alternative procedures that have been 
considered and an explanation on why alternative procedures were not included. Risk associated with the 
procedures in this protocol are minimal. Participation in this study is voluntary and separate from medical care; 
therefore, patients enrolled will be informed verbally and in writing that they may withdraw at any time without 
giving reason and without penalty. 
1.3.2 
Known Potential Benefits 
Immediate potential benefits. It is possible that the sleep extension protocol will improve sleep duration, 
daytime function, and cardio-metabolic risk profile. 
Long-range potential benefits. Participants may gain some satisfaction that their participation will advance our 
understanding of the relationship between sleep and MetS that may someday improve preventative efforts. 
2 
Objectives and Purpose 
The purpose of this pilot study is to determine the acceptability and feasibility of a sleep extension 
intervention in middle age adults with MetS. We will also compare pre- and post-intervention differences in 
sleep duration, MetS risk behaviors, symptoms associated with MetS risk behaviors and self- regulation. 
2.1 
Primary Objective 
To test the feasibility and acceptability of a self-management for adequate sleep intervention (SASI) in 
community-dwelling, short-sleeping, middle-aged adults with MetS. 
2.2 
Secondary Objectives (if applicable) 
The secondary objectives are to compare differences between pre- and post-intervention sleep duration, 
MetS risk behaviors (physical activity, sedentary behavior, diet quality), symptoms associated with MetS risk 
behaviors (affective well-being, fatigue) and self-regulation. We will also explore the perceived barriers and 
facilitators of SASI (e.g., socio-ecological factors). 
3 
Study Design and Endpoints 
3.1 
Description of Study Design 
This single site, one group, pilot study will test the acceptability and feasibility of the Self- management for 
Adequate Sleep Intervention (SASI) in racially/ethnically diverse middle-aged adults with MetS. 
This is an 18-week study. In the first 2 weeks, baseline data will be collected. During week 3, the baseline data 
will be used to confirm study eligibility based on objectively estimated short sleep and to plan the personalized 
intervention. During weeks 4 to 15, the study team will call or videoconference participants once a week to 
prescribe a sleep schedule based on their daily sleep diaries. At the end of week 15, participants will be asked 
to schedule their final visit within 3 weeks. 

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Acceptability data will be collected at two time points (i.e., pre- intervention and at the final visit). The final visit 
will include a 30-minute open ended interview to explore perceived facilitators and barriers to implementing 
SASI. The intake visit will take place at the CTSI. The final visit will take place using video conferencing 
technology such as WebEx. Weekly contact with the study team will take place during the intervention weeks 
so that SASI can be personalized based on individual responses to the sleep intervention. This weekly contact 
will be remote in the form of telephone calls or remote video conferencing technology. 
3.2 
Study Endpoints 
3.2.1 
Primary Study Endpoints 
This pilot study is designed to test the acceptability and feasibility of SASI. The primary endpoint, acceptability, 
will be evaluated by the percentage of participants rating SASI as acceptable (overall acceptability survey 
scores greater than 21), neutral (overall acceptability survey scores equal to 21), and unacceptable (overall 
acceptability survey scores less than 21) at each of two time points (pre- intervention and post intervention). 
The feasibility endpoints will be determined by the 1) recruitment rate: the percentage of potential participants 
screened in order to enroll 60 participants 2) attrition rate: the percentage of enrolled participants completing 
the 18-week study. Participants will be considered withdrawn after 4 weeks of not responding to phone 
calls/emails during the intervention and the 3) protocol adherence rates: the percentage of participants 
completing greater than or equal to 4 daily sleep diary entries per week for 80% or more of the intervention 
period. 
3.2.2 
Secondary Study Endpoints 
Secondary endpoints will be evaluated by pre- and post-intervention sleep duration, physical activity, 
sedentary behavior, diet quality, smoking, alcohol use, affective well-being, morning fatigue, evening fatigue, 
and self- regulation measurements. These secondary endpoints were chosen to gain preliminary evidence of 
relationships between SASI and sleep duration, MetS risk behaviors, as well as symptoms associated with 
MetS risk behaviors, and self-regulation. Elucidating these relationships will inform potential pathways 
through which SASI impacts MetS. 
3.2.3 
Exploratory Endpoints 
Exploratory endpoints are the perceived barriers and facilitators of SASI. These will be identified through 
bivariate correlations between specific socio-ecological factors associated with sleep duration changes. 
Qualitative data analysis from the post intervention interviews will be conducted. Identifying perceived 
barriers and facilitators will lead to future tailoring and/or targeting of SASI. 
4 
Study Enrollment and Withdrawal 
To reach a final sample of N= 60, we will recruit 220 individuals. Of these, we anticipate that 65% will become 
ineligible through the multi-stage screening process and 20% will be lost to attrition during the intervention 
leaving 60 participants with evaluable data. 
4.1 
Inclusion Criteria 
To be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Greater than or equal to 35 years of age and less than or equal to 60 years of age. Middle aged 
adults have the highest prevalence of short sleep compared to other stages of adulthood8,34. 
2. Objectively confirmed MetS factors defined by one or more of the following: a) waist 
circumference greater than 120cm (men) or 88cm (women), b) blood pressure greater than or 
equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive 
medication use, c) fasting glucose greater than or equal to 110 mg/dL or insulin or oral 
hypoglycemic medication use, d) serum triglycerides greater than or equal to 150mg/dL or 
hypertriglyceride medication use, e) HDL-c less than 40mg/dL (women) or less than 50 mg/dL 
(men) or medication use for low HDL-c1. MetS was selected because individuals with MetS are 
at high risk for multiple chronic conditions35. 

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3. Accelerometry confirmed short sleep (average work day sleep less than or equal to 6 
hours/night). Self-reported sleep may overestimate sleep duration. This will ensure that 
participants will have short sleep patterns that are associated with MetS outcomes. 
4. English speaking. Participants will need to demonstrate adequate English comprehension 
(assessed during informed consent). 
4.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Pregnancy/lactation (self-reported). Pregnancy and lactation can disrupt habitual sleep patterns, 
and hormonal changes during pregnancy increase insulin resistance and may confound MetS37. 
2. Current chemotherapy treatments (self-reported). Current chemotherapy treatments may 
contribute to fatigue and sleep disturbances38. 
3. Alcohol abuse will be assessed with the Alcohol Use Disorders Identification Test (a measure 
that has demonstrated good reliability and validity). Alcohol abuse/dependence may contribute 
to sleep disturbances and limit the participant’s ability to take part in sleep interventions39. 
Individuals with scores > 15 (men) or > 13 (women) will be excluded. 
4. Night shift or shift work (previous 2 months), trans-meridian travel (previous 4 weeks), or 
planned shift work or trans-meridian travel during intervention period (self-reported). These will 
be to ensure that sleep estimates from baseline represent participants’ habitual sleep and to 
ensure adherence with the sleep intervention. 
5. Moderate-severe or severe depression will be assessed with the Patient Health Questionnaire 
(PHQ-9). The PHQ-9 is reliable and has been shown to have construct and criterion validity 
(Kroenke et al, 2001). Using professional interviews as the criterion standard, a PHQ-9 score of 
10 had a sensitivity of 88% and a specificity of 88% for detecting major depression. It has been 
validated in clinical populations and been used in a large number of cardiovascular studies. 
Moderate-severe depression or severe depression may contribute to sleep disturbances40 and 
interfere with the participant’s ability to adhere to the sleep interventions. Therefore, individuals 
with scores ≥ 15 will be excluded. 
6. Chronic use of sleep-promoting medications (self-reported) defined as taking a sleep-promoting 
medication ≥ 3 nights per week. These may interfere with sleep patterns and limit the 
participant’s ability to take part in the sleep interventions. 
7. Habitual napping, defined as 2 naps per day or > 90 minutes of napping on 3 or more days of 
the week will be assessed during baseline with accelerometry. This will be to ensure adherence 
with the sleep intervention. 
8. Untreated OSA, defined by an apnea hypopnea index (AHI)> 10 using the hypopnea scoring 
criteria of a 4% or more oxyhemoglobin saturation. This criterion has been used because of its 
independent association with cardiovascular disease (Punjabi et al 2008, Punjabi et al 2013). 
9. Any condition that, in opinion of the PI, will interfere with the safe completion of the study.  
4.3 
Vulnerable Subjects 
No special classes of people who may be considered vulnerable populations (e.g., fetuses, neonates, pregnant 
women, children less than 16 years of age, prisoners, institutionalized individuals) will be recruited into the 
study. 
4.4 
Strategies for Recruitment and Retention 
Recruitment. Recruitment strategies will include 1) electronically posting IRB-approved flyers at NYULH, NYU 
College of Dentistry, NYU College of Nursing, Seastreak commuter ferries and ferry terminals, and metro 
terminals, 2) advertising in the community so interested individuals can contact the study team, 3) 
posting/distributing IRB-approved flyers in the community and in clinics, 4) contacting Co-I’s past study 
participants who agreed to be contacted for future research studies, 5) using Epic to identify potential 
participants (see section below on using DataCore for recruitment/identification purposes, and 6) sending IRB-
approved study recruitment messages to potential study volunteers using research registries such as Research 
Match. Subject identification and recruitment are described in detail below. 

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Retention. We will offer an incentive for completing each of the study visits, as well as for completing 
6 weeks of the SASI intervention (Total incentive: $100). Multiple means of contact will be collected 
for enrolled participants, including email, mailing address, and phone number. Reminders for study 
visits will be sent via email, if available, or via one of the other means of contact. 
4.4.1 Electronically-posted flyers 
IRB-approved electronic flyers will be posted at selected sites with permission from the site. Potential sites include NYULH, 
NYU College of Dentistry, NYU College of Nursing, Seastreak commuter ferries and ferry terminals, and metro terminals. 
Interested persons responding to the flyers will be contacted by the RA and provided with the option of proceeding with the 
IRB-approved verbal telephone consent and screening. See study flyer attached with study team contact information. 
4.4.2 
Advertising in the community 
Community members may learn of the study through electronically-posted flyers (see Section 4.4.1), or other methods, such 
as radio talk shows (e.g. NYU Langone Nurse Radio, sleep apnea support groups). Interested community members may 
contact the study team for more information about the study. After contacting the study team, the RA will provide individuals 
with the option of proceeding with the IRB-approved verbal telephone consent and screening. 
4.4.3 
Posted/distributed flyers 
Flyers promoting the study will be available to individuals who visit the participating health facilities (see Section 4.4.4 NYU 
Langone Health Recruitment for more detailed information). Flyers will also be distributed at community sites so that 
interested individuals can contact the study team. Those responding to the distributed flyer will be contacted by the RA and 
provided with the option of proceeding with the IRB-approved verbal telephone consent and screening. 
4.4.4 
NYU Langone Health recruitment 
This study will recruit individuals from settings affiliated with NYU Langone Health, such as employee health, occupational 
medicine, cardiology, endocrinology, and college of nursing faculty practices. Flyers promoting this study will be available to 
individuals who visit the participating health facilities or attend employee health events (e.g. flu shot clinics, health fairs). 
Clinical staff informed of the study protocol and provided with the IRB-approved study information may also inform individuals 
about the study and refer them to the study team to contact if interested in participating in the study. With approval of the clinic 
site, the research staff will also be available at the clinic site during specific hours to facilitate recruitment. 
4.4.5 Past study participants 
Only past study participants from the Co-I’s previous studies who agreed to be contacted for future studies will be contacted 
by the RA. Contacted individuals expressing interest in the study will be provided with the option of proceeding with the IRB-
approved verbal telephone consent and screening. 
4.4.6 
Use of DataCore/Epic Information for Recruitment Purposes 
A study team member will submit a request to DataCore to identify potential participants. Data points to be 
searched will include age, blood pressure measurements, fasting glucose, serum triglycerides, HDL-c, 
medication use (antihypertensives, insulin, oral hypoglycemic, hypertriglyceridia medication, or medication 
use for low HDL-c) within the last 6 months. A DataCore query will be run at the start of the study and six 
months after the study start depending on recruitment rates. DataCore will request a report from EPIC for 
these patients with identifiable protected health information (name, email address) for research related 
purposed. Only study team members with Epic access will have access to the search results. 
The Epic team will set up a recruitment message in MyChart and work with the PI and project coordinator to 
send it out. The IRB-approved MyChart recruitment message is attached. The text will include a description 
of the study, inclusion and exclusion criteria, and contact information for the PI (phone number and email). 
The recruitment message may be repeated two times at two-month intervals if needed for subject recruitment 
(total 3 Epic MyChart messages). 
These data will be used solely for participant identification in order to determine patients who are initially 
eligible and for chart review (previous 12-month blood specimen results from Co-investigator’s study). The 
study team will discard information from those who do not wish to participate in the study. If a subject 
requests information regarding opting out of further recruitment for all research, subjects will be directed to 

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contact the study coordinator or have subjects contact research-contact- optout@nyumc.org or 1-855-777-
7858. 
4.4.7 Research Match 
We will also utilize Research Match (ResearchMatch.org), a national, electronic, web-based  
recruitment tool that was created through the Clinical and Translational Science Awards Consortium in 2009 
to send study recruitment messages to potential study participants. This study’s recruitment content will be 
inserted into the standard Research Match electronic notification that informs possible matched participants 
that they have been identified as a potential match for this study. The Research match recruitment message 
is attached. The secure Research Match clearinghouse will route this standard Research Match notification 
to each of these Research Match participants. These potentially matching participants will have the option 
of replying “yes”, “no”, or “not respond” through a set of quick links available in this notification of the study 
announcement. The contact information of the “yes” responding participants will be made available on the 
PI’s “Manage my Study” dashboard. A member of the research team will contact the individual who 
expresses interest and provide the option for the verbal/telephone consent and screening or an in-person 
meeting. If a subject requests information regarding opting out of further recruitment for all research, 
subjects will be directed to contact the study coordinator or have subjects contact research-contact-
optout@nyumc.org or 1-855-777- 7858. 
4.5 
Duration of Study Participation 
The study is expected to last 18 weeks. This period includes the initial visit at the CTSI, the first 2 weeks of 
baseline data collected during the participant’s everyday routine, a third week to evaluate the sleep baseline 
data to confirm short sleep using the accelerometry data and to plan the personalized intervention, weeks 4-15 
delivering the SASI intervention, and then a final visit by WebEx videoconferencing within 3 weeks of 
completing the intervention. 
4.5.1 
Reasons for Withdrawal or Termination 
Participants are free to withdraw from participation in the study at any time upon request. An investigator may 
terminate participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs 
such that continued participation in the study would not be in the best interest of the participant 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) 
that precludes further study participation. 
• 
The participant does not respond to phone calls/emails for 4 weeks during the intervention. 
4.5.2 
Handling of Participant Withdrawals or Termination 
Participants will be considered withdrawn if they cannot be contacted for 4 weeks during the intervention 
using all of the contact information collected. No further efforts will be made to contact the participant and 
that participant will be considered lost to follow-up. Abrupt termination of participation in the study 
intervention poses no safety risk to participants. As this study is minimal risk, efforts will not be made to 
collect safety and efficacy data after withdrawal. 
Any data collected before withdrawal from the study will be retained for analysis, and no new data will be 
collected. If the participant requests that data be destroyed, all paper records will be shredded, and any data 
already processed into computer files will be removed. However, if results based on the participant's data 
have been submitted for publication or presentation before the request is made, the results cannot be 
removed from the publication or presentation. 
4.5.3 
Premature Termination or Suspension of Study 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. 
Written notification, documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party to the PI and the appropriate funding agency, and New York University IRB. 
If the study is prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the 
reason(s) for the termination or suspension. As this study will evaluate acceptability, feasibility, and 
preliminary efficacy, it will not be possible to determine whether the intervention is efficacious or futile for the 
population studies. Circumstances that may warrant termination or suspension include, but are not limited 
to: 

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• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
If the study is temporarily suspended, the study may resume once concerns about safety, protocol compliance, 
data quality is addressed and satisfy the sponsor and/or IRB. 
5 
Behavioral/Social Intervention 
5.1 
Study Behavioral or Social Intervention(s) Description 
SASI, is based on Cognitive Behavioral Therapy for Insomnia (CBTI). SASI differs from CBTI because the first 
step of sleep restriction prescribed by CBTI is not used in SASI. This is because the participants have already 
been verified as short-sleepers. However, SASI does employ CBTI’s gradual approach for increasing sleep 
time and applies it to short sleepers. The 12-week intervention period of gradually increasing sleep duration by 
advancing bedtimes 15 minutes per week (or 1 hour per month) will provide the time needed to increase sleep 
duration in habitual 5 hour sleepers to the recommended 7 to 8 hour sleep duration. Like CBTI, SASI extends 
sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed 
times and wake times will be prescribed each week for each participant and allow for gradual increases in 
sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains >90%. 
Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be 
changed because wake times are often determined by external demands, such as work schedules. There will 
be no control intervention in this pilot study. 
5.1.1 
Administration of Intervention 
This intervention will be delivered by a trained study team member for 15 weekly sessions that consist of 
approximately 15 to 30-minute phone calls or NYU WebEx videoconferencing based on the participant’s 
preference. During these individual weekly sessions, the participant and the study team member will review 
the participant’s previous week’s consensus sleep diary, discuss challenges implementing the sleep 
intervention, and determine the work day bedtime-wake time schedule for the upcoming week. Daily text 
message or email reminders will be sent to participants to complete their daily sleep diary as needed. 
5.1.2 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity 
The PI and trained study team members will be responsible for administering the intervention. We will use 
recommendations of the Treatment Fidelity Workgroup of the NIH Behavior Change Consortium45 to enhance 
SASI fidelity. The treatment fidelity plan includes audiotaping of each SASI session and reviewing content 
against an a priori performance checklist to ensure consistency in SASI delivery. Treatment fidelity will be 
monitored by the research team with guidance from Dr. Dickson, Co-investigator. Barriers to implementing SASI 
will be identified and resolved together with the participant and the PI or Co-I’s. 
5.1.3 
Assessment of Subject Compliance with Study Intervention 
The study team will track feasibility data, including completion of daily sleep diaries and retention rates. 
Participant engagement will be assessed through attendance records for weekly sessions and by the number 
of sleep diaries completed each week. Daily texts or email reminders will be sent to participants to remind them 
to complete the diary as needed. 

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6 
Study Procedures and Schedule 
6.1 
Study Procedures/Evaluations 
6.1.1 
Study Specific Procedures 
Participants meeting the telephone screen eligibility criteria will be invited to the CTSI for an intake visit 
(CTSI visit 1). The enrollment procedures at the CTSI visit 1 will include the 1) informed consent process, 
2) further screening for eligibility using surveys, and 3) further screening to objectively confirm MetS 
(anthropometric measurements and 3 ml. blood draw if needed for glucose and lipids). (Participants will 
have the option of providing an optional 8ml blood sample for blood storage.). 
Assessments will be done at the following time points: 1) CTSI visit 1, 2) during 2-week baseline assessment 
at home, 3) during the last 2-weeks of the intervention, and 4) within three weeks of completing the 
intervention (Final visit – at home). 
The screening surveys, physical exam, and blood draw will be completed at the CTSI at Bellevue Hospital 462 
1st Avenue, New York, NY 10016 in C/D Building, 4th Floor New York, NY. About 220 subjects will be in the 
study. Accelerometry, pulse oximetry (as needed), acceptability (pre- and post- intervention), Composite Scale 
of Morningness, Economic Vulnerability Survey, Family Assessment Device – General Functioning Scale, 36-
item Short Form Health Survey (SF-36) version 1, ASA24, Demographics- SDOH: Alcohol use (AUDIT C), 
Demographics – SDOH: Tobacco use, Index of Self- regulation, SAFTEE questionnaire, Sleeping Environment 
Survey, PROMIS Fatigue 6a –morning, PROMIS Fatigue 6a – evening, Epworth Sleepiness Scale, Daily sleep 
diaries, acceptability survey (post- intervention), and the open-ended interview will take place at home. 
Demographic and Clinical Characteristics. 
• 
Demographic: 
o 
BRICS NINR Demographic Data Elements o BRICS NINR 
Demographics (with race clarifying questions) 
o 
BRICS Demographics - Diagnosis 
• 
General health questions (self-reported) o Pregnancy/lactation o Current 
chemotherapy treatments o Habitual napping o Sleep promoting 
medication use (prescribed or over the counter) o Cardio-metabolic 
disease medication use: 
 
insulin 
 
oral hypoglycemic medication 
 
anti-hypertensive medications 
 
hypertriglyceridemia medication 
 
medications for low HDL-c 
• 
Physical exam: All measurements will be completed by a qualified and 
trained RA. 
o 
Height o Weight o BMI 
o 
Waist circumference o Blood pressure 
 
average of 3 recordings each taken 1 minute apart, following 10 minutes of inactivity. 
 
A 4th recording will occur if any two systolic or diastolic readings are >5 mmHg apart. 
o Neck circumference 
Surveys. Participants enrolled in the study will be asked to complete several surveys. All surveys will be 
completed using REDCap. At home surveys will be administered through the Assessment Center  
Application Programming Interface in REDCap (Research Electronic Data Capture). For the PROMIS-fatigue 
morning scale and the PROMIS-fatigue evening scale, the REDCap system will be programed to send two 
separate timed emails, at each time point, to subjects with instructions to answer the questions based on how 
they felt when they woke up for morning fatigue severity and how they felt when they went to bed for evening 
fatigue severity. 
• 
CTSI visit 1 surveys o BRICS NINR Demographic Data elements o 
BRICS NINR Demographics (with race clarifying questions) 
o 
BRICS Demographics - Diagnosis 

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o 
ARES 
o 
Alcohol Use Disorders Identification Test (AUDIT) 
o 
General health questions  
o PHQ-9  
o Primary Care Provider  
o Contact form 
• 
Baseline Surveys (weeks 1 or 2) 
 
Acceptability survey (pre-intervention) 
 
Composite Scale of Morningness 
 
Economic Vulnerability Survey 
 
Family Assessment Device – General Functioning Scale 
 
Sleeping Environment Survey 
 
36-item Short Form Health Survey (SF-36) version 1 
 
ASA24 
• 
The ASA24 (ASA24-2016) is a freely available web-based tool designed 
to collect self-report dietary recall data. While under- reporting and 
inaccuracy in self-report of dietary intake is a known limitation, 24-hour 
recalls provide more accurate data than other screeners or food 
frequency questionnaires, and the ASA24 has demonstrated similar 
criterion validity against actual food intaketo other more complex and 
time consuming recall methods. 
 
Demographics – SDOH: Alcohol use (AUDIT C) 
 
Demographics – SDOH: Tobacco use 
 
Index of Self-Regulation 
 
SAFTEE questionnaire 
 
PROMIS-Depression 6a 
• 
End of study surveys at home (week 15) o 36-item Short Form Health 
Survey (SF-36) version 1 
o 
ASA24 
 
The ASA24 (ASA24-2016) is a freely available web-based tool designed to collect 
self-report dietary recall data. While under-reporting and inaccuracy in self-report of 
dietary intake is a known limitation, 24-hour recalls provide more accurate data than 
other screeners or food frequency questionnaires, and the ASA24 has demonstrated 
similar criterion validity against actual food intaketo other more complex and time 
consuming recall methods. 
o 
Demographics – SDOH: Alcohol use (AUDIT C)  
o 
Demographics – SDOH: Tobacco use 
o 
Index of Self-Regulation 
o 
 o SAFTEE questionnaire 
o 
PROMIS- Depression 6a 
• 
Intervention surveys at home (weeks 1-15) o Epworth Sleepiness Scale 
(weekly) o PROMIS Fatigue 6a - morning (weekly) o PROMIS Fatigue 6a 
- evening (weekly) o Sleep Diary (daily) 
Objective Sleep and Physical Activity Measures. Participants will wear a wrist accelerometer 24/7 for 14 
continuous days during the first 2 weeks of baseline data collection and the last 2 weeks of the SASI 
intervention. The accelerometer may be removed for bathing and contact sports. Data collected from the 
accelerometer will be used to estimate sleep duration and physical activity levels. A wrist worn fitbit will also be 
worn during the 2-week baseline and 12 week SASI intervention by the study by participants. 
Objective OSA Measures. Participants being treated for OSA will wear a pulse oximeter on their fingertip for 
one night during the first 2-week baseline data collection. 
Training and Treatment Fidelity: SASI facilitators will be individuals with prior training and experience 
delivering sleep interventions. Facilitators will complete training in intervention content and telephone 

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facilitation skills through didactic instruction and roleplaying. They will be trained to refer participants to their 
providers for any medical questions. 
All sessions will be digitally audio-recorded using a WebEx conference call line recording capability. A subset 
of 20% of SASI sessions will be reviewed to evaluate treatment fidelity and provide feedback to intervention 
facilitators. Facilitators’ degree of adherence to the protocol will be rated using a SASI Adherence Scale. 
6.1.2 
Standard of Care Study Procedures 
Not applicable. 
6.2 
Laboratory Procedures/Evaluations 
6.2.1 
Clinical Laboratory Evaluations 
Biochemistry: Participants without evidence of fasting glucose, triglyceride, and HDL-c results during the 
previous 12 months will have 3 ml. in total blood drawn at CTSI Visit   1. 
Participants recruited from outside the Langone system will have the option to provide documentation of their 
most recent blood work. Long term changes in blood lipid levels has been documented as small (0.7% per 
year) (Glaszious et al 2008). This approach is consistent with other studies examining the relationship between 
sleep and metabolic outcomes whereby most recent bloodwork from subject’s medical records were used 
(Reutrakul et. Al 2015). 
The blood specimens will be collected at the NYU Langone Health CTSI Clinical Research Center (CRC) at 
Bellevue Hospital C/D Building, 4th floor by the Clinical Research Coordinators. The estimated total volume of 
blood drawn is 3 ml (for participants needing a fasting glucose, triglyceride, and HDL-c analyses). All 
vacutainer tubes will be labeled with participants’ unique study ID without PHI (e.g. P20+123). The unique 
study ID will stored in a locked cabinet in the PI’s locked office. 
Analysis will be completed at the CTSI lab using standard techniques for analyzing the blood samples. The 
laboratory will report the results through the CRC EMR integration with the NYU Clinical Research 
Management System and REDCap. 
Table 1: Biomarker collection for MetS verification 
 
 
 
Biomarker 
Volume 
required 
Specimen type 
Collection tube 
Lab analysis method 
Collection 
requirement 
FBG 
1 ml 
serum 
Red top 
spectrophotometry 
Fasting 8 hours prior 
to collection 
TG 
1 ml. 
serum 
Light green PST 
gel and lithium 
heparin 
spectrophotometry 
Fasting 8 hours prior 
to collection 
HDL-c 
1 ml. 
serum 
Light green PST 
gel and lithium 
heparin 
spectrophotometry 
Fasting 8 hours prior 
to collection 
Research Subjects will be asked to abstain from food, alcohol use, recreational drug use, and caffeinated 
beverages for 8 hours before the blood collection. Blood will be collected by peripheral vein venipuncture by 
the coordinators at the CRC between 0800-1000 to control for diurnal variation and to support subject 
abstinence requirements. Additionally, to control for diurnal variability we will document the time the patient 
awoke and evaluate the time lapse during analysis. 
6.2.2 
Other Assays or Procedures  
Future use of Stored Specimens 
De-identified optional blood samples will be stored for future analysis of biomarkers of metabolic disorders or other health 
conditions, no genetic material will be collected. These optional blood samples will be collected, used, stored, distributed, and 
transferred only in accordance with all applicable laws and regulations, all applicable policies of NYU Langone Health, NYU 
Langone Health’s IRB Policies and Procedures and the written consent and authorization signed by the research subject. The 

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protocol submitted, reviewed and approved by NYU Langone Health’s IRB will guide the collection of all biomarkers. Written 
informed consent signed by the research subject will be obtained before any blood samples are collected. 
Subjects can opt-out of the optional blood draw and the storage of these specimens in the biorepository through a question on 
the written consent form. 
Subjects will not be contacted when their stored samples are used for future analysis, as they will provide their consent to store 
and use their samples until they are used up at the time of informed consent. If a subject revokes his/her consent to allow 
storage of his/her samples, the samples will not be drawn. 
Purpose of Future Research 
The specimens will be shared with members of the research team and the P20 center at NYU Meyers. With the authorization of 
the PI and the P20 center director the samples will be made available to researchers whose scope of work would fall under the 
scope described in the consent and this protocol for analysis of metabolic conditions and other health conditions. 
Type of Sample and Amount 
The optional 20 ml. of whole blood will be drawn in an EDTA tube. Fasting will not be required. 
Location of Storage and Security Protections 
The optional blood specimens obtained for future analysis will be hand transported from the data collection site to the 
biorepository at the NYU Rory Meyers College of Nursing 433 First Ave New York NY 10010. The Research Assistant will log in 
the specimen for storage in the defined storage space for the study. The repository is secured by an alarm, the code for which 
will be known only to the research staff. With the authorization of the PI and the P20 center directors the samples will be made 
available to researchers whose research meets the requirements of federal regulations and the IRB. 
Duration of Storage for Future Research 
The specimens will be stored until they are used up, or if the subject requests to withdraw their specimen from future use. 
Subjects will be informed that they can withdraw their specimens at any time and if they so request, the specimens will be 
destroyed and not used for future research. 
Labeling of and Access to Stored Specimens  
The stored samples will be identified by a unique study ID number without PHI. We will keep one separate and password- 
protected and encrypted computer file that contains identifiable data that is necessary to keep if subjects contact us to withdraw 
their samples from storage (phone numbers, email, and U.S. mailing addresses). This file will be the only file that can link 
subject names, addresses, and/or telephone numbers to the study unique codes and is only accessible by the study PI. 
The PI and members of the P20 research team will have access to the specimens. 
7.3 Study Schedule 
7.3.1 Screening 
Telephone Screening (within 4 weeks of CTSI visit 1) 
• 
Telephone screen administered (Duration: approximately 15 minutes) o If eligible and 
interested, schedule CTSI visit 1 within 4 weeks of the telephone screen 
• 
Figure 1 for Multi-stage Screening and Enrollment Flowchart 
Figure 1: Multi-stage Screening and Enrollment Flowchart 

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7.3.2 Enrollment/Baseline 
Enrollment Visit (CTSI Visit 1, within 4 weeks of screening interview): Duration of visit: approximately 
120 minutes 
• 
Review informed consent form and, if desired by potential participant, obtain written informed 
consent. Provide copy of signed form to participant. 
• 
Review intervention audio consent and, if desired by potential participant, obtain written audio 
consent. Provide copy of signed form to participant. 
• 
See Table 2 for eligibility measurements and surveys during CTSI Visit 1 
Table 2: Eligibility tests and surveys during Enrollment CTSI Visit 1 
 
 
Number of  
measurements/volume/que 
stions 
Estimated time 
Anthropometric measurements 
 
Height 
3 
30 minutes 
Weight 
1 
Waist circumference 
3 
Neck circumference 
1 
Blood pressure 
3-4 
Blood Draw within 12 months of visit 1 
 
FBG 
1 ml 
15 minutes 
TG 
1 ml. 
 
HDL-c 
1 ml. 
Optional blood sample stored for future analyses 
20 ml. 

 St u d y N u m b er: 1 8- 0 0 7 0 7 
Pa ge 2 1  
Versi o n Date: Se pte m b er 2 7, 2 0 1 9  
C O N FI D E N TI A L  
T his material is t he pr o pert y of t he N Y U Sc h o ol  of Me dici ne a n d La n g o ne Me dic al C e nter. D o n ot dis cl os e or us e e xc e pt as 
a ut h ori ze d i n writi n g b y t he st u d y s p o ns or Be ha vi oral I nter ve nti o n T e mplate Versi o n: 5 M A Y 2 0 1 7  
S ur v e y s  
 
 
B RI C S NI N R D e m o gr p a hi c D at a El e m e nt s  
n/ a  
St u d y t e a m e nt er s  
B RI C S NI N R D e m o gr a p hi c s wit h r a c e cl arif yi n g 
q u e sti o n  
1 4  
< 5 mi n ut e s  
B RI C S NI N R D e m o gr a p hi c s - Di a g n o si s  
n/ a  
St u d y t e a m e nt er s 
A R E S q u e sti o n n air e  
1 7  
< 5 mi n ut e s  
A U DI T  
1 0  
5 mi n ut e s  
G e n er al h e alt h q u e sti o n s  
1 0  
< 5 mi n ut e s  
P H Q -9  
9  
< 5 mi n ut e s  
Pri m ar y C ar e Pr o vi d er  
5  
< 5 mi n ut e s  
C o nt a ct F or m  
1 2  
< 5 mi n ut e s  
T O T A L TI M E  
 
~ 7 5 mi n ut e s  
• 
I n str u ct p arti ci p a nt o n t h e u s e of t h e f oll o wi n g ( 2 0 mi n ut e s t ot al): 
o  wri st a c c el er o m et er o  c o n s e n s u s sl e e p di ar y o  s ur v e y s t o b e c o m pl et e d 
d uri n g t h e 2 -w e e k b a s eli n e h o m e a s s e s s m e nt.  
• 
Arr a n g e f or a m et h o d ( d ail y t e xt s a n d/ or e m ail s s e nt t hr o u g h a s e c ur e e m ail s er v er) f or 
p arti ci p a nt s t o r e c ei v e r e mi n d er s t o c o m pl et e t h e d ail y sl e e p di ari e s a s n e e d e d.  
• 
Arr a n g e f or a c o n v e ni e nt d a y of w e e k a n d ti m e f or t h e p arti ci p a nt t o r e c ei v e w e e kl y p h o n e or 
vi d e o c o nf er e n ci n g c all s d uri n g t h e i nt er v e nti o n p eri o d.  
7. 3. 3 I nt er m e di at e Vi sit s  
W e e k 1: B a s eli n e D at a C oll e cti o n  
• 
S e e T a bl e 3 f or st u d y r el at e d pr o c e d ur e s d uri n g w e e k 1  
• 
S e e T a bl e 4 f or b a s eli n e s ur v e y s t o b e c o m pl et e d d uri n g w e e k 1 or 2.  
• 
D ail y t e xt s a n d/ or e m ail s will b e s e nt t hr o u g h a s e c ur e e m ail s er v er t o r e mi n d t o p arti ci p a nt s 
t o c o m pl et e t h e d ail y sl e e p di ari e s a s n e e d e d  
Arr a n g e f or pi c k u p or U P S r et ur n of p ul s e 
o xi m et er a s n e e d e d.  
T a bl e 3: B a s eli n e D at a C oll e cti o n W e e k 1  
 
 
 
N u m b er of ti m e s t o 
c o m pl et e p er w e e k  
N u m b er of 
q u e sti o n s  
E sti m at e d ti m e  
Wri st a c c el er o m et er a n d fit bit  
W e ar 2 4/ 7  
n/ a  
n/ a  
P ul s e o xi m et er ( a s n e e d e d p er 
pr ot o c ol)  
W e ar f or 1 ni g ht  
n/ a  
n/ a  
D ail y sl e e p di ar y  
7  
9  
< 5 mi n ut e s/ d a y  
< 3 5 mi n ut e s/ w e e k  
P R O MI S F ati g u e 6 a -m or ni n g  
1  
6  
< 5 mi n ut e s  
P R O MI S F ati g u e 6 a - e v e ni n g  
1  
6  
< 5 mi n ut e s  
E p w ort h Sl e e pi n e s s S c al e  
1  
8  
< 5 mi n ut e s/ w e e k  
T O T A L TI M E  
 
< 5 0 mi n ut e s/ w e e k  

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Table 4: Baseline Surveys Completed during Baseline Weeks 1 or 2 
 
 
Number of questions 
Estimated time 
Acceptability Survey (pre-intervention) 
7 
< 5 minutes 
Composite Scale of Morningness 
13 
5 minutes 
Economic Vulnerability Survey 
8 
5 minutes 
Family Assessment Device – General 
Functioning Scale 
12 
< 5 minutes 
Sleeping Environment Survey 
11 
5 minutes 
36-item Short Form Health Survey (SF- 
36) version 1 
36 
40 minutes 
ASA24 
varies 
24 minutes 
Demographics – SDOH: Alcohol use 
(AUDIT C) 
3 
< 5 minutes 
Demographics – SDOH: Tobacco use 
2 
< 5 minutes 
Index of Self-Regulation 
9 
5 minutes 
SAFTEE 
128 
10 minutes 
PROMIS Depression 6a 
6 
< 5 minutes 
TOTAL TIME 
~114 minutes 
7.3.3.2 Week 2: Baseline Data Collection 
• 
Record adverse events as reported by participant or observed by investigator. 
• 
See Table 5 for study related procedures. 
• 
Daily texts and/or emails sent through a secure email server will be sent to remind to 
complete the daily sleep diaries as needed 
• 
Arrange for the pick-up or UPS return of the accelerometry devise. 
• 
Arrange for convenient date/time to call or WebEx videoconference during week 3. 
Table 5: Baseline Data Collection Week 2 
 
 
 
Number of times to 
complete per week 
Number of 
questions 
Estimated time 
Wrist accelerometer and fitbit 
Wear 24/7 
n/a 
n/a 
Daily sleep diary 
7 
9 
< 5 minutes/day 
< 35 minutes/week 
PROMIS Fatigue 6a morning 
1 
6 
< 5 minutes 
PROMIS Fatigue 6a evening 
1 
6 
< 5 minutes 
Epworth Sleepiness Scale 
1 
8 
< 5 minutes 
TOTAL TIME 
 
~50 minutes/week 
7.3.3.3 Week 3 
• 
The study team will evaluate participants ongoing eligibility for SASI based on the 
accelerometry data confirming that participants are short sleepers. 
• 
Contact participants to notify them of their eligibility status for the SASI intervention phase of 
the study. 
 
Retained participants are those who have objectively confirmed MetS , 
objectively confirmed short sleep based on the 2-week baseline home sleep 
test, and objectively confirmed treatment of OSA, if applicable. 
• 
For retained participants, review baseline week 2 sleep diary data from work days to prescribe 
bed times and wake times for the first week of the intervention. 
• 
Administer the study intervention in accordance with the SASI protocol. 
 
Briefly, bedtimes will be set 15 minutes earlier each week provided sleep 
efficiency remains >90%. Earlier betimes will extend sleep duration by 
increasing the opportunity for sleep. Wake times will not be changed because 

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wake times are often determined by external demands, such as work 
schedules. 
• 
Arrange for the weekly phone or WebEX videoconferencing meeting to administer the 
intervention for the following week. 
7.3.3.4 Week 4 
• 
Participant will initiate new sleep schedule as prescribed by the study team. 
• 
See Table 6 for study related procedures. 
• 
Send daily text message or email reminders via a secure email server to participants to 
complete their daily sleep diary as needed. 
• 
Record participant’s adherence to the intervention program. 
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Arrange for the weekly phone or WebEx videoconferencing meeting to administer the 
intervention for the following week. 
Table 6: SASI Data Collection Weeks 4 – 13 
 
 
 
Number of times to 
complete per week 
Number of 
questions 
Estimated time 
Fitbit 
Wear 24/7 
n/a 
n/a 
Daily sleep diary 
7 
9 
< 5 minutes/day 
< 35 minutes/week 
PROMIS Fatigue 6a morning 
1 
6 
< 5 minutes/week 
PROMIS Fatigue 6a evening 
1 
6 
< 5 minutes/week 
Epworth Sleepiness Scale 
1 
8 
< 5 minutes/week 
TOTAL TIME 
 
< 50 minutes/week 
7.3.3.5 Weeks 5-13 
• 
Participant will initiate new sleep schedule each week as prescribed by study team. 
• 
See Table 6 for study related procedures. 
• 
Send daily text message or email reminders via a secure email server to participants to 
complete their daily sleep diary as needed. 
• 
Record participant’s adherence to the intervention program. 
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Arrange for the weekly phone or WebEx videoconferencing meeting to administer the 
intervention for the following week 
• 
Week 13: Arrange for the delivery of the accelerometry devise by the study team or UPS. 
7.3.3.6 Week 14 
• 
Participant will initiate new sleep schedule as prescribed by the study team. 
• 
See Table 7 for study related procedures. 
• 
Send daily text message or email reminders via a secure email server to participants to 
complete their daily sleep diary as needed. 
• 
Arrange for the weekly phone or WebEX videoconferencing meeting to administer the 
intervention for the following week. 
• 
Record participant’s adherence to the intervention program. 
• 
Record adverse events as reported by participant or observed by investigator. 
Table 7: Data Collection Week 14 
 
 
 
Number of times to 
complete per week 
Number of 
questions 
Estimated time 
Wrist accelerometer and fitbit 
Wear 24/7 
n/a 
n/a 
Daily sleep diary 
7 
9 
< 5 minutes/day 
< 35 minutes/week 

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PROMIS Fatigue 6a morning 
1 
6 
< 5 minutes 
PROMIS Fatigue 6a evening 
1 
6 
< 5 minutes 
Epworth Sleepiness Scale 
1 
8 
< 5 minutes/week 
TOTAL TIME 
 
< 50 minutes/week 
7.3.3.7 Week 15 
• 
Participant will initiate new sleep schedule as prescribed by the study team. 
• 
See Table 8 for study related procedures 
• 
Send daily text message or email reminders via a secure email server to participants at a 
mutually agreed upon time to remind them to complete their daily sleep diary. 
• 
Record participant’s adherence to the intervention program. 
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Arrange for the return of the accelerometry devise to the study team or UPS 
• 
Arrange for a date and time for the final CTSI visit 2 (Time Point 2, post-intervention) within 
three weeks of completing the intervention 
Table 8: Data Collection Week 15 
Number of times to 
complete per week 
Number of questions 
Estimated time 
Wrist accelerometer and fitbit 
Wear 24/7 
n/a 
n/a 
Daily sleep diary 
7 
9 
< 5 minutes/day 
< 35 minutes/week 
PROMIS Fatigue 6a morning 
1 
6 
< 5 minutes 
PROMIS Fatigue 6a evening 
1 
6 
< 5 minutes 
Epworth Sleepiness Scale 
1 
8 
< 5 minutes 
36-item Short Form Health  
Survey (SF-36) version 1 
1 
36 
40 minutes 
ASA24 
1 
varies 
24 minutes 
Demographics – SDOH: Alcohol 
use (AUDIT C) 
1 
3 
< 5 minutes 
Demographics – SDOH: Tobacco 
use 
 
1 
2 
< 5 minutes 
Index of Self-Regulation 
1 
9 
5 minutes 
SAFTEE 
1 
128 
10 minutes 
PROMIS Depression 6a 
1 
6 
< 5 minutes 
TOTAL TIME 
~140 minutes/week 
7.4 Final Study Visit (within 3 weeks of completing SASI): Duration < 60minutes 
• 
Record any new medications prescribed during the study period to treat hyperglycemia, 
hypertension, hypertriglyceridemia, or low HDL-c. 
• 
See Table 10 for study related procedures. 
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Notify participant that aggregate-level results will be available after dissemination of study 
findings begins. 
• 
Instruct participant to report any subsequent event(s) that the participant, or the participant’s 
physician, believes might reasonably be related to participation in this study. 
Table 10: Final Study Visit (at home) 
 
 
Number of questions 
Estimated time 
Acceptability survey (post intervention) 
7 
< 5 minutes 

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Open ended interview 
varies 
30 minutes 
TOTAL TIME 
~ 35 minutes 
7.5 Withdrawal Visit 
If a participant withdraws or is withdrawn from the study, no further study visits or procedures will be 
completed. 
7.6 Unscheduled Visit 
Not applicable. 
7.7 Concomitant Medications, Treatments, and Procedures 
Any medications prescribed by treating health care provider for hyperglycemia, hypertension, 
hypertriglyceridemia, or low HDL-c levels during study participation will be recorded on the case report forms 
(CRFs). For this protocol, a prescription medication is defined as a medication that can be prescribed only by a 
properly authorized/licensed clinician. 
8 Assessment of Safety 
8.1 Specification of Safety Parameters 
The study will involve no more than minimal risk to research participants. The probability and magnitude of 
harm or discomfort anticipated for this research are not greater than what this same population encounters in 
daily life or during the performance of physical or psychological examinations or tests. The only alternative to 
study participation is non-participation. 
8.1.1 Definition of Adverse Events (AE) 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. 
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• 
results in study withdrawal 
• 
is associated with a serious adverse event 
• 
is associated with clinical signs or symptoms 
• 
leads to additional treatment or to further diagnostic tests 
• 
is considered by the investigator to be of clinical significance 
8.1.2 Definition of Serious Adverse Events (SAE) 
Serious Adverse Event 
Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: 
• 
fatal 
• 
life-threatening 
• 
requires or prolongs hospital stay 
• 
results in persistent or significant disability or incapacity 
• 
a congenital anomaly or birth defect 
• 
an important medical event 
Important medical events are those that may not be immediately life threatening, but are clearly of major 
clinical significance. They may jeopardize the subject, and may require intervention to prevent one of the other 
serious outcomes noted above. For example, drug overdose or abuse, a seizure that did not result in in-patient 
hospitalization, or intensive treatment of bronchospasm in an emergency department would typically be 
considered serious. 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious adverse 
events. 

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8.1.3 Definition of Unanticipated Problems (UP) 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria: 
• 
Unexpected in nature, severity, or frequency (i.e. not described in study-related documents such 
as the IRB-approved protocol or consent form, the investigators brochure, etc.) 
• 
Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the 
procedures involved in the research) 
• 
Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 
8.2 Classification of an Adverse Event 
8.2.1 Severity of Event 
For AEs not included in the protocol defined grading system, the following guidelines will be used to describe 
severity. 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities. 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating. 
8.2.2 Relationship to Study Intervention 
The clinician’s assessment of an AE's relationship to study intervention is part of the documentation process, 
but it is not a factor in determining what is or is not reported in the study. If there is any doubt as to whether a 
clinical observation is an AE, the event should be reported. All AEs must have their relationship to study 
intervention assessed. In a clinical trial, the study intervention must always be suspect. To help assess, the 
following guidelines are used. 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility that 
the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study intervention 
caused the event, there is no temporal relationship between the study intervention and event onset, or 
an alternate etiology has been established. 
8.2.3 Expectedness 
Dr. Malone will be responsible for determining whether an AE is expected or unexpected. An AE will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk 
information previously described for the study intervention. As this study is minimal risk, no adverse events are 
expected. 
9.3 Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant presenting for medical care, or upon review by a study monitor. All AEs 
including local and systemic reactions not meeting the criteria for SAEs will be captured on the appropriate RF. 
Information to be collected includes event description, time of onset, clinician’s assessment of severity, 
relationship to study intervention (assessed only by those with the training and authority to make a diagnosis), 

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and time of resolution/stabilization of the event. All AEs occurring while on study must be documented 
appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
Any medical condition that is present at the time that the participant is screened will be considered as baseline 
and not reported as an AE. However, if the study participant’s condition deteriorates at any time during the 
study, it will be recorded as an AE. UPs will be recorded in the data collection system throughout the study. 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at 
each level of severity to be performed. AEs characterized as intermittent require documentation of onset and 
duration of each episode. 
The PI will record all reportable events with start dates occurring any time after informed consent is obtained 
until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, 
the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for 
outcome information until resolution or stabilization. 
All unresolved adverse events should be followed by the investigator until the events are resolved, the subject 
is lost to follow-up, or the adverse event is otherwise explained. At the last scheduled visit, the investigator 
should instruct each subject to report any subsequent event(s) that the subject, or the subject’s personal 
physician, believes might reasonably be related to participation in this study. The investigator should notify the 
study sponsor of any death or adverse event occurring at any time after a subject has discontinued or 
terminated study participation that may reasonably be related to this study. 
9.4 Reporting Procedures – Notifying the IRB 
9.4.1 Adverse Event Reporting 
AEs are not expected due to participation in this minimal risk study. However, AE forms will be completed at 
each of the study assessments as well as any AEs reported during the weekly intervention sessions. 
Study participants will be encouraged to contact study staff immediately should any AEs occur during study 
participation. Periodic adverse event reporting will include any AE that occurs while a participant is on the 
research protocol, regardless of whether it is considered related to study participation. 
The PI will submit as part of annual progress reports to the IRB a summary of monitoring that took place; 
cumulative adverse event data; assessments that were performed to evaluate external factors or relevant 
information that may have an impact on the safety of study participants or ethics of the research study; 
outcomes of procedural reviews conducted to ensure participant privacy and confidentiality; and final 
conclusions regarding changes to the anticipated risk-to-benefit ratio of study participants and 
recommendations related to continuing, changing, or terminating the study. 
9.4.2 Serious Adverse Event Reporting 
SAEs are not expected due to participation in this minimal risk study. The procedure for AE reporting will be 
followed for SAEs. In addition, if a serious adverse event occurs, it will be reported in a timely fashion after 
adjudication: All SAE reports will be made to the IRB within 5 working days; any participant deaths will be 
reported to the NINR Program Officer within 24 hours of realization, and all other serious adverse events will 
be reported to NINR within 72 hours of realization. 
9.4.3 Unanticipated Problem Reporting 
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of an UP report 
form. It is the site investigator’s responsibility to report UPs to their IRB and to the DCC/study sponsor. The UP 
report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• 
A detailed description of the event, incident, experience, oroutcome; 
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP; 

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• 
A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP. 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
• 
UPs that are SAEs will be reported to the IRB and to the study sponsor within the timeframe 
described in 8.4.2 
• 
Any other UP will be reported to the IRB and to the study sponsor within the timeframe described in 
8.4.1 for AEs. 
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s written 
reporting procedures), the supporting agency head (or designee), and OHRP within the Time frame 
described for AEs or SAEs, as appropriate, after the IRB’s receipt of the report of the UP from the 
investigator. 
9.4.4 Reporting of Pregnancy 
Pregnant or breastfeeding participants will not be able participate in the study because pregnancy and lactation 
can disrupt habitual sleep patterns, and hormonal changes during pregnancy increase insulin resistance and 
may confound MetS37. If participants become pregnant during the course of the study, their data will not be 
used in the analyses. 
10.5 Reporting Procedures – Notifying the Study Sponsor 
The study clinician will complete a SAE Form within the following timelines: 
• 
All deaths and immediately life-threatening events, whether related or unrelated, will be recorded on 
the SAE Form and submitted to the DCC/study sponsor within 24 hours of site awareness. See 
Section 1, Key Roles for contact information. 
• 
Other SAEs regardless of relationship will be submitted to the DCC/study sponsor within 72 hours of 
site awareness. 
All SAEs will be followed until satisfactory resolution or until the site investigator deems the event to be chronic 
or the adherence to be stable. Other supporting documentation of the event may be requested by the 
DCC/study sponsor and should be provided as soon as possible. 
As a follow-up to the initial report, within the following 48 hours of awareness of the event, the investigator shall 
provide further information, as applicable, on the unanticipated event or the unanticipated problem in the form 
of a written narrative. This should include a copy of the completed Unanticipated Problem form, and any other 
diagnostic information that will assist the understanding of the event. Significant new information on ongoing 
unanticipated adverse effects shall be provided promptly to the study sponsor. 
10.6 Reporting Procedures – Participating Investigators 
As the study intervention and data collection will be conducted only at NYU, procedures for monitoring and 
reporting across sites are not provided. 
10.7 Study Halting Rules 
As this study is minimal risk, it is not anticipated that the study may be halted. However, if there is a 
determination of unexpected, significant, or unacceptable risk to participants, the study may be 
temporarily suspended or prematurely terminated as described in section 6.7. 
10.8 Safety Oversight 
It is the responsibility of the Principal Investigator to oversee the safety of the study at his/her site. This safety 
monitoring will include careful assessment and appropriate reporting of adverse events as noted above, as well 
as the construction and implementation of a site data and safety-monitoring plan. Medical monitoring will 
include a regular assessment of the number and type of serious adverse events. 

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Following are plans for data and safety monitoring during the pilot study. 
Monitoring entity. This study will be monitored by the PI, the research coordinator, the bio-statistician, and 
the IRB. The PI will ensure that the research coordinator and statistician undergo training in the study 
protocol. The research coordinator will also be trained in the safety protocol for depression. The PI will 
oversee adherence to the study protocol to ensure the safety, reliability, and validity of data collection. The PI 
will be responsible for submitting all necessary reports to the study sponsor and the IRB. The research 
coordinator will prepare weekly reports on participant demographics, recruitment, attrition, data collection, 
data entry updates, and any other issues or concerns since the last research team meeting. The statistician 
will prepare monthly reports about missing, invalid, or inconsistent data on selected key variables. The reports 
will also contain a summary of monthly accrual and cumulative accrual, a summary of key characteristics of 
the study participants, and a summary of the completeness and quality of data. 
Monitoring Study Safety. Once enrollment is initiated, the PI will arrange weekly meetings. These meetings 
will consist of retrospective and concurrent evaluation of all research procedures, including participant 
screening for inclusion/exclusion criteria, the informed consent process, and participant study instructions, 
as well as any necessary staff training in the IRB approved study protocol. Participant demographics, 
recruitment, retention, data collection, and data entry updates will be monitored weekly. 
Quality control assurances of data will be reviewed in monthly meetings and will include information about 
missing, invalid, inconsistent data on selected key variables, and a summary of key characteristics of the study 
participants. A random sample of participants’ research records will be reviewed to ensure compliance with IRB 
requirements, conformance with informed consent requirements, verification of source documents, and 
investigator compliance by the PI monthly. Meetings will also be arranged by the PI if an adverse event occurs. 
Minimizing research-associated risk. We do not believe that there are any major risks associated with the 
proposed study, although a subject may be identified with moderate/severe or severe depression. This is not a 
research-associated risks but may be detected during screening or participation in the study. The sleep 
intervention and accelerometry monitoring have minimal risk. Trained research personnel will perform all 
testing and will be monitored by the PI. Throughout the study, the PI and the research coordinator will monitor 
participants for adverse events and for adherence to the study protocols. We have developed the following 
medical alert and reporting policies: 
1. ARES questionnaire 
a. Scores greater than or equal to six. 
i. 
Send letter to participant and the participant’s primary care provider, if 
available, referring the participant to a nearby sleep disorders center for 
further evaluation and treatment. 
2. Depression 
Depressive symptoms will be assessed using PHQ-9 during the screening interview. Individuals identified 
with moderate/severe or severe depression during the screening interview will not be enrolled in the 
intervention phase of the study as per study protocol. If moderate/severe or severe depression is 
identified, a medical alert and reporting policy has been developed along with a Depression Safety and 
Referral Plan (see Depression Safety and Referral Protocol and Arranging Care). 
a. PHQ-9 score ≥15 
i 
During screening, the interviewer will proceed to assess the participant for 
thoughts of suicide using the Columbia-Suicide Severity Rating Scale, before 
continuing with other pre-screening surveys. The interviewer shall stay with the 
participant during this time and proceed with the response protocol for the 
Columbia-Suicide Severity Rating Scale based on the participant responses, as 
well The Depression Safety and Referral Protocol and Arranging Care. 
Participant Screening and Enrollment. When individuals are contacted to determine their interest in 
participating in the study, no language will be used that will indicate any study opportunity/eligibility or personal 
health information unless research personnel are speaking directly with the party of interest. All data from 
participants screened for the study will be entered into the Research Electronic Data Capture (REDCap). The 
collected data will be helpful in examining the patient population and feasibility of enrollment criteria and will 
include gender, age, race, and reason for exclusion. For retained participants, the research staff will collect 

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and enter required data (written informed consent and demographics) onto study data forms in REDCap. 
Individuals will be assigned a unique study ID number. 
This study ID number will be linked to the participant name only. Only the PI and the research coordinator will 
have access to the linkage between the participant identity and the study identification number. This linking file 
will be password protected and stored on a secure NYU server separate from study data. This linking file will 
be destroyed at closure of the study, and the study will remain open with the IRB until these identifiers are 
destroyed. The unique study identification number will be used on all data forms, and no personal identifiers 
will be connected to the data. Paper records, such as the informed consent documents, will be kept in a locked 
file cabinet in a locked office. All data will be reported in aggregate. 
Binders. The research coordinator will prepare and maintain a participant-specific binder for each participant 
containing all non-electronic Case Record Files. A regulatory file will also be maintained to include the IRB- 
approved protocol, original informed consent documents, and other study-related regulatory documents. All 
paper research records and case record files will be maintained in a locked file cabinet in a secure facility 
within the College of Nursing. Access to the research records, study database and PHI’s will be restricted to 
study personnel as approved by the PI and IRB. 
Data entry, processing, monitoring. This study will use REDCap for data capture and management. Data 
exports will be limited to the PI, the research coordinator, and the statistician for generating reports and 
conducting statistical data analysis. Weekly meetings will include reports on participant recruitment and 
retention, adverse events, and protocol deviations. Monthly meetings will consist of summaries of monthly 
accrual and cumulative accrual, key characteristics of the study participants, and the completeness and 
quality of data. Information on missing, invalid, and inconsistent data on selected key variables will be 
reviewed. 
Data Security. All data will be saved in an electronic database on a secure NYU server. All system logins, data 
entries, and data updates are recorded, enabling efficient data tracking. Access to the server is available only 
to authorized users with passwords; overall data security is ensured by a firewall. Additional security is 
provided by database software requiring a password for data entry and allowing for password protection at 
the record level within a database. Patient confidentiality will be ensured by eliminating from the design of the 
data systems any information that could be used to identify individual participants. Each participant will be 
identified in the database only by a project-specific ID number. Identifiable information (e.g., name, birthdate, 
home address, or other personal information) will not be stored on any of the devices used in this study. For 
mobile devices and software such as the tablets or cell phones that will be used to gather survey data, 
guidelines established by NYU IRB will be followed including documentation of security controls, incident 
response program, compliance certifications, privacy practices, physical data security, and subcontractors. 
The packages that are shipped to and from study participants will not have any information on the exterior of 
the box indicating that they are a research participant. 
External factors. The PI will monitor developments in the literature as the study progresses. Should it 
become clear that the intervention would be in any way harmful to participants, would increase risk, or would 
be unethical to continue, the IRB and study sponsor will be notified and the study will be stopped. 
Futility analysis. As this pilot study is designed to determine acceptability and feasibility for a future well-
powered R01 application, it will not be possible to determine whether the intervention is futile for this 
population during the proposed study. 
11 Clinical Monitoring 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are protected, 
that the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in 
compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory 
requirement(s). 

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Authorized representatives of the IRB and the NINR may review de-identified information, as well as 
participants’ identifiable information, for the purposes of assuring proper conduct of the research, addressing 
a specific reported incident, or verifying appropriate use of funds. The Quality Assurance and Quality 
Improvement Division of NYU’s Research and Regulatory Services may audit the study to confirm 
compliance. Access of any protected health information will be done in the offices of the PI in his presence. 
No identifiable information may be copied or taken off-site. 
The project manager (or clinical research coordinator) will audit one case per quarter, selected at random, 
to confirm compliance with IRB requirements, including conformance with informed consent requirements, 
verification of source documents, and investigator compliance. 
12 Statistical Considerations 
12.1 Statistical and Analytical Plans 
A formal SAP will be developed for this study in consultation with the study biostatistician. Only a general 
overview of study statistics is included in this protocol. 
12.2 Statistical Hypotheses 
The sample size is too small to make inferences about relationships evaluated in the pilot study to the larger 
population of middle aged adults with MetS. For the primary aim, acceptability will be evaluated by the 
percentage of participants rating SASI as acceptable (overall acceptability survey scores greater than 21), 
neutral (overall acceptability survey scores equal to 21), and unacceptable (overall acceptability survey 
scores less than 21) on the Acceptability Survey at each of two time points (pre- intervention and post 
intervention). Feasibility will be evaluated by the 1) recruitment rate: the percentage of potential participants 
screened in order to enroll 60 participants with evaluable data, 2) attrition rate: the percentage of enrolled 
participants completing the 18-week study. Participants will be considered withdrawn after 4 weeks of not 
responding to phone calls/emails during the intervention, and the 3) protocol adherence rates: the percentage 
of participants completing greater than or equal to 4 daily sleep diary entries per week for 80% or more of the 
intervention period. For the secondary endpoints, paired t-tests will be used to compare the mean pre-
intervention and mean post-intervention estimates for SAFTEE scores, physical activity, sedentary behavior, 
diet quality, smoking, alcohol use, affective well-being, morning fatigue, evening fatigue, and self- regulation 
measurements. For the exploratory endpoints of perceived barriers and facilitators of SASI, bivariate 
correlations between specific socio-ecological factors and sleep duration change will be identified. The 
qualitative data from the post intervention interviews will be analyzed using content analysis. Content analysis 
includes a line- by-line review that yields clusters of data that are coded. This coding is linked to interview 
questions. Summarization of coding will be performed across individual interviews, and subsequently cross- 
classified to yield a rich descriptive analysis. Emerging themes within and across interviews will be identified, 
and review of fit with data verified. 
12.3 Analysis Datasets 
The analysis dataset will include all participant (e.g., intent to treat). 
12.4 Description of Statistical Methods 
12.4.1 General Approach 
This is a 1-group pretest-posttest pilot study of the acceptability and feasibility of a sleep intervention. 
Using descriptive analyses, the investigators will describe each variable using measures of central tendency 
(means, medians) and variability (standard deviations, interquartile ranges) for continuous variables; counts 
and percentages for categorical variables. Data will be evaluated for anomalies (e.g., nonrandom missing data, 
erroneous outliers, multicollinearity, possible confounding) that may invalidate planned analyses. Data 
transformations, imputation, and/or robust and tailored analysis approaches will be used for non-normally 
distributed variables. 

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12.4.2 Analysis of the Primary Efficacy Endpoint(s) 
For Aim 1: Acceptability will be based on the pre- and post-intervention acceptability survey measurements. 
The acceptability survey is an ordinal scale with higher scores indicating greater acceptability. Results will be 
reported as a categorical outcome indicating the count and percentage of participants rating SASI at the pre- 
intervention assessment as well as the post intervention assessment as acceptable (total scores greater than 
or equal to 21), neutral (total score equal to 21), and unacceptable (total scores less than 21). 
Feasibility will be based on recruitment, retention, and study protocol adherence. Recruitment will be measured 
as the number and percentage of participants screened and their determination as eligible or ineligible based 
on inclusion/exclusion criteria. Results will be reported as a recruitment rate indicating the count and 
percentage of participants eligible and ineligible. Attrition rates will be reported as the number 
and percentage of participants who withdraw from the study. Attrition rates >20% will suggest lack of feasibility. 
Recruitment and attrition rates will also be examined for differences in specific subgroups. Study protocol 
feasibility will be indicated by percentage of participants providing at least 4 work day sleep diaries per week 
for greater than or equal to 80% of the intervention period. 
12.4.3 Analysis of the Secondary Endpoint(s) 
The main secondary endpoint of interest is sleep duration. Paired-samples t-tests will be used to compare 
differences in repeated measures of sleep duration (baseline and intervention). Mean sleep duration will be 
calculated as a weighted mean using the formula [(weekday sleep duration x 5) + weekend sleep duration x 
2)]/7. Weekday nights will be Sunday through Thursday nights; weekend nights will be Friday and Saturday 
nights. The primary secondary outcome for sleep duration data will be obtained from the two-week baseline 
sleep dairy data and the last two weeks of intervention sleep diary data. Other secondary endpoints that will 
be compared between baseline and intervention using paired sample t-tests include measures for 1) diet 
quality (defined as the percentage of fat, percentage of carbohydrate, and total caloric intake estimated from 
the ASA24 at baseline and intervention), 2) physical symptoms (estimated from SAFTEE Questionnaire), 3) 
cigarette and alcohol use estimated from the Demographics- SDOH: Alcohol use (AUDIT C), Demographics 
– SDOH: Tobacco use , 4) affective well-being (estimated from 36-item Short Form Health Survey (SF-36) 
version 1) self- regulation (estimated from the Index for Self-regulation), 6) physical activity (defined as 
moderate/vigorous [100-429 millgravity units] and light [10-99 millgravity units]) estimated from the two- 
week baseline accelerometry data and the last two weeks of the intervention accelerometry data, and 8) 
sedentary behavior (defined as less than 10 millgravity units) estimated from the two-week baseline 
accelerometry data and the last two weeks of the intervention accelerometry data. 
12.4.4 Safety Analyses 
As this study is minimal risk, it is not anticipated that the study may be halted. However, if there is a 
determination of unexpected, significant, or unacceptable risk to participants, the study may be 
temporarily suspended or prematurely terminated. 
12.4.5 Adherence and Retention Analyses 
Adherence and retention are the primary endpoints for this pilot study. 
12.4.6 Baseline Descriptive Statistics 
Baseline characteristics, including demographic and clinical characteristics of the sample, using descriptive 
statistics will be compared between participants for whom the intervention was acceptable and for whom the 
intervention was unacceptable at each time point (pre-intervention and post- intervention). Inferential statistics 
will not be used. 
12.4.7 Planned Interim Analysis. 
The research coordinator will prepare weekly reports on participant demographics, recruitment, attrition, and 
protocol adherence. The statistician will prepare monthly reports about missing, invalid, or inconsistent data 
on selected key variables. The reports will also contain a summary of monthly accrual and cumulative accrual, 

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a summary of key characteristics of the study participants, and a summary of the completeness and quality of 
data. 
12.4.7.1 Safety Review 
As this study is minimal risk, it is not anticipated that the study may be halted. However, if there is a 
determination of unexpected, significant, or unacceptable risk to participants, the study may be temporarily 
suspended or prematurely terminated. 
12.4.7.2 Efficacy Review 
This study will not evaluate efficacy. 
12.4.8 Additional Sub-Group Analyses 
Primary or secondary endpoints may be analyzed for descriptive purposes by age, race/ethnicity, or any other 
participant characteristic as described in detail in the SAP. 
12.4.9 Multiple Comparison/Multiplicity 
Not applicable. 
12.4.10 Tabulation of Individual Response Data 
For these analyses, the investigators will generally not control for multiple comparisons. 
12.4.11 Exploratory Analyses 
Explore the perceived barriers and facilitators of SASI (e.g., socio-ecological factors). 
12.5 Sample Size 
Our final sample size is N=60. To achieve this, it is anticipated that 220 interested potential participants will go 
through the telephone screening procedures. The reason we will need to screen 220 is because OSA is often a 
co-morbid condition with MetS and we anticipate 65% of participants screened will become ineligible after the 
initial CTSI visit33. We also anticipate that 20% will not complete the study protocol. 
12.6 Measures to Minimize Bias 
12.6.1 Enrollment/Randomization/Masking Procedures 
Not applicable. 
12.6.2 Evaluation of Success of Blinding 
Not applicable. 
12.6.3 Breaking the Study Blind/Participant Code 
Not applicable. 
13 Source Documents and Access to Source Data/Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a clinical 
trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source 
documents. Examples of these original documents, and data records include: hospital records, clinical and 
office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing 
records, recorded data from automated instruments, copies or transcriptions certified after verification as 
being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, 

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authorized in writing by the study sponsor Behavioral Intervention Template Version: 5 MAY 2017 
subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments 
involved in the clinical trial. 
The study case report form (CRF) is the primary data collection instrument for the study. All data requested on 
the CRF must be recorded. All missing data must be explained. If a space on the CRF is left blank because 
the procedure was not done or the question was not asked, write “N/D”. If the item is not applicable to the 
individual case, write “N/A”. All entries should be printed legibly in black ink. If any entry error has been made, 
to correct such an error, draw a single straight line through the incorrect entry and enter the correct data 
above it. All such changes must be initialed and dated. DO NOT ERASE OR WHITE OUT ERRORS. For 
clarification of illegible or uncertain entries, print the clarification above the item, then initial and date it. 
Access to study records will be limited to IRB-approved members of the study team. The investigator will permit 
study-related monitoring, audits, and inspections by the IRB/EC, the sponsor, government regulatory bodies, 
and University compliance and quality assurance groups of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data etc.). The investigator will ensure 
the capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 
14 Quality Assurance and Quality Control 
QC procedures will be implemented beginning with the data entry system and data QC checks that will be run 
on the database will be generated. Any missing data or data anomalies will be communicated to the site(s) for 
clarification/resolution. 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory 
requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
The investigational site will provide direct access to all trial related sites, source data/documents, and reports 
for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
15 Ethics/Protection of Human Subjects 
15.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for the Protection of 
Human Subjects of Research codified in 45 CFR Part 46. 
15.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials have been 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be 
obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by 
the IRB before the changes are implemented to the study. All changes to the consent form will be IRB 
approved; a determination will be made regarding whether previously consented participants need to be re-
consented. 
15.3 Informed Consent Process 
15.3.1 Consent/Assent and Other Informational Documents Provided to Participants  
Consent forms describing in detail the study intervention, study procedures, and risks are given to the participant 
and written documentation of informed consent is required prior to starting intervention. The following consent 

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materials are submitted with this protocol Informed Consent, audio consent for interview during the final study 
visit. 
15.3.2 Consent Procedures and Documentation 
Information will be obtained during screening for the study by the study team to determine eligibility. During 
screening, study staff will review the purpose, nature, risks, and benefits of the study; and determine eligibility. 
The period of time between recruitment and enrollment will be less than or equal to four weeks. This process 
will give the potential participant time to consider whether he/she wants to participate in the study. Participants 
will be reminded when the study is introduced, during recruitment and screening that participation is voluntary 
and that choosing not to participate in no way affects the quality or quantity of medical or nursing care provided 
to them. If at any point the candidate prefers not to proceed, the enrollment visit will be canceled. The 
candidate will be offered time after the in-person review of the consent form during the enrollment visit to think 
about her potential participation and to ask any questions before choosing to sign the study consent. In 
addition, participants are told that they may choose to withdraw from the study at any time. 
Audio informed consents will be obtained for the fidelity checks and for the 30-minute audio-taped open 
ended interview during the final visit. As indicated above, participants will be reminded that participation is 
voluntary and that choosing not to participate in no way affects the quality or quantity of medical or nursing 
care provided to them. The candidate will be offered time after the in-person review of the consent form to 
think about her potential participation and to ask any questions before choosing to sign the study consent. In 
addition, participants are told that they may choose to withdraw from the study at any time. 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study and 
continues throughout the individual’s study participation. Extensive discussion of risks and possible benefits 
of participation will be provided to potential participants. Consent forms will be IRB-approved and the 
participant will be asked to read and review the document. The investigator will explain the research study to 
the participant and answer any questions that may arise. All participants will receive a verbal explanation in 
terms suited to their comprehension of the purposes, procedures, and potential risks of the study and of their 
rights as research participants. The participant will sign the informed consent document prior to any 
procedures being done for the study. The participants may withdraw consent at any time throughout the 
course of the trial. A copy of the signed informed consent document will be given to the participants for their 
records. A copy of the signed informed consent document will be stored in the participant’s research record. 
The consent process, including the name of the individual obtaining consent, will be thoroughly documented 
in the subject’s research record. Any alteration to the standard consent process and the justification for such 
alteration will likewise be documented. 
15.4 Participant and Data Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations require a signed 
subject authorization informing the subject of the following: 
o What protected health information (PHI) will be collected from subjects in this study o 
Who will have access to that information and why o Who will use or disclose that information 
o The rights of a research subject to revoke their authorization for use of their PHI. 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains 
the ability to use all information collected prior to the revocation of subject authorization. For subjects that have 
revoked authorization to collect or use PHI, attempts should be made to obtain permission to collect at least 
vital status (i.e. that the subject is alive) at the end of their scheduled study period. 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the sponsor(s) 
and their agents. This confidentiality is extended to cover testing of biological samples and genetic tests in 
addition to the clinical information relating to participants. Therefore, the study protocol, documentation, data, 
and all other information generated will be held in strict confidence. No information concerning the study or the 
data will be released to any unauthorized third party without prior written approval of the sponsor. 

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authorized in writing by the study sponsor Behavioral Intervention Template Version: 5 MAY 2017 
The study monitor, other authorized representatives of the sponsor, or representatives of the IRB may inspect 
all documents and records required to be maintained by the investigator, including but not limited to, medical 
records (office, clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site 
will permit access to such records. 
The study participant’s contact information will be securely stored at each clinical site for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for as long a period as 
dictated by local IRB and Institutional regulations. 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored in the research offices of the PI at the NYU Meyers College of Nursing. This will not 
include the participant’s contact or identifying information. Rather, individual participants and their research 
data will be identified by a unique study identification number. The study data entry and study management 
systems used by clinical sites and by NYU Meyers College of Nursing research staff will be secured and 
password protected. At the end of the study, all study databases will be de-identified and archived at the NYU 
Meyers College of Nursing. 
To further protect the privacy of study participants, a Certificate of Confidentiality will be obtained from the NIH. 
This certificate protects identifiable research information from forced disclosure. It allows the investigator and 
others who have access to research records to refuse to disclose identifying information on research 
participation in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, 
or local level. By protecting researchers and institutions from being compelled to disclose information that 
would identify research participants, Certificates of Confidentiality help achieve the research objectives and 
promote participation in studies by helping assure confidentiality and privacy to participants. 
16 Data Handling and Record Keeping 
16.1 Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site PI. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported. 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of data. 
Black ink is required to ensure clarity of reproduced copies. When making changes or corrections, cross out 
the original entry with a single line, and initial and date the change. DO NOT ERASE,  
OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for 
recording data for each participant enrolled in the study. Data reported in the eCRF derived from source 
documents should be consistent with the source documents or the discrepancies should be explained and 
captured in a progress note and maintained in the participant’s official electronic study record. 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data will be entered into REDCap, a data capture system provided by the New York University. The 
data system includes password protection and internal quality checks, such as automatic range checks, to 
identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the 
source documents. 
16.2 Study Records Retention 
Study documents will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It is the 
responsibility of the sponsor to inform the investigator when these documents no longer need to be retained. 
16.3 Protocol Deviations 

 St u d y N u m b er: 1 8- 0 0 7 0 7 
Pa ge 3 7  
Versi o n Date: Se pte m b er 2 7, 2 0 1 9  
C O N FI D E N TI A L  
T his material is t he pr o pert y of t he N Y U Sc h o ol  of Me dici ne a n d La n g o ne Me dic al C e nter. D o n ot dis cl os e or us e e xc e pt as 
a ut h ori ze d i n writi n g b y t he st u d y s p o ns or Be ha vi oral I nter ve nti o n T e mplate Versi o n: 5 M A Y 2 0 1 7  
A pr ot o c ol d e vi at i o n i s a n y n o n c o m pli a n c e wit h t h e cli ni c al tri al pr ot o c ol, G C P, or M O P r e q uir e m e nt s. T h e 
n o n c o m pli a n c e m a y b e eit h er o n t h e p art of t h e p arti ci p a nt, t h e i n v e sti g at or, or t h e st u d y sit e st aff. A s a r e s ult 
of d e vi ati o n s, c orr e cti v e a cti o n s ar e t o b e d e v el o p e d b y t h e sit e a n d i m pl e m e nt e d pr o m ptl y.  
T h e s e pr a cti c e s ar e c o n si st e nt wit h I C H E 6:  
• 
4. 5 C o m pli a n c e wit h Pr ot o c ol, s e cti o n s 4. 5. 1, 4. 5. 2, a n d 4. 5. 3  
• 
5. 1 Q u alit y A s s ur a n c e a n d Q u alit y C o ntr ol, s e cti o n 5. 1. 1  5. 2 0 
N o n c o m pli a n c e, s e cti o n s 5. 2 0. 1, a n d 5. 2 0. 2.  
It i s t h e r e s p o n si bilit y of t h e sit e t o u s e c o nti n u o u s vi gil a n c e t o i d e ntif y a n d r e p ort d e vi ati o n s wit hi n t hr e e 
w or ki n g d a y s of i d e ntifi c ati o n of t h e pr ot o c ol d e vi ati o n, or wit hi n t hr e e w or ki n g d a y s of t h e s c h e d ul e d pr ot o c ol -
r e q uir e d a cti vit y. All d e vi ati on s m u st b e a d dr e s s e d i n st u d y s o ur c e d o c u m e nt s, r e p ort e d t o N Y U I R B a s p er 
t h eir g ui d eli n e s. Pr ot o c ol d e vi ati o n s m u st b e r e p ort e d t o t h e l o c al I R B p er t h eir g ui d eli n e s. T h e sit e PI/ st u d y 
st aff i s r e s p o n si bl e f or k n o wi n g a n d a d h eri n g t o t h eir I R B r e q uir e m e n t s. F urt h er d et ail s a b o ut t h e h a n dli n g of 
pr ot o c ol d e vi ati o n s will b e i n cl u d e d i n t h e M O P.  
1 6. 4 P u bli c ati o n a n d D at a S h ari n g P oli c y  
T hi s st u d y will c o m pl y wit h t h e NI H P u bli c A c c e s s P oli c y, w hi c h e n s ur e s t h at t h e p u bli c h a s a c c e s s t o t h e 
p u bli s h e d r e s ult s of NI H f u n d e d r e s e ar c h. It r e q uir e s s ci e nti st s t o s u b mit fi n al p e er -r e vi e w e d j o ur n al 
m a n u s cri pt s t h at ari s e fr o m NI H f u n d s t o t h e di git al ar c hi v e P u b M e d C e ntr al u p o n a c c e pt a n c e f or p u bli c ati o n.  
T h e I nt er n ati o n al C o m mitt e e of M e di c al J o ur n al E dit or s (I C M J E)  m e m b er j o ur n al s h a v e a d o pt e d a cli ni c al tri al s 
r e gi str ati o n p oli c y a s a c o n diti o n f or p u bli c ati o n. T h e I C M J E d efi n e s a cli ni c al tri al a s a n y r e s e ar c h pr oj e ct t h at 
pr o s p e cti v el y a s si g n s h u m a n s u bj e ct s t o i nt er v e nti o n or c o n c urr e nt c o m p ari s o n or c o ntr ol gr o u p s t o st u d y t h e 
c a u s e- a n d -eff e ct r el ati o n s hi p b et w e e n a m e di c al i nt er v e nti o n a n d a h e alt h o ut c o m e. M e di c al i nt er v e nti o n s 
i n cl u d e dr u g s, s ur gi c al pr o c e d ur e s, d e vi c e s, b e h a vi or al tr e at m e nt s, pr o c e s s-of -c ar e c h a n g e s, a n d t h e li k e. 
H e alt h o ut c o m e s i n cl u d e a n y  bi o m e di c al or h e alt h -r el at e d m e a s ur e s o bt ai n e d i n p ati e nt s or p arti ci p a nt s, 
i n cl u di n g p h ar m a c o ki n eti c m e a s ur e s a n d a d v er s e e v e nt s. T h e I C M J E p oli c y, a n d t h e S e cti o n 8 0 1 of t h e F o o d 
a n d Dr u g A d mi ni str ati o n A m e n d m e nt s A ct of 2 0 0 7, r e q uir e s t h at all cli ni c al  tri al s b e r e gi st er e d i n a p u bli c tri al s 
r e gi str y s u c h a s Cli ni c al Tri al s. g o v, w hi c h i s s p o n s or e d b y t h e N ati o n al Li br ar y of M e di ci n e. Ot h er bi o m e di c al 
j o ur n al s ar e c o n si d eri n g a d o pti n g si mil ar p oli ci e s. F or i nt er v e nti o n al cli ni c al tri al s p erf or m e d u n d er NIH I C 
gr a nt s a n d c o o p er ati v e a gr e e m e nt s, it i s t h e gr a nt e e’ s r e s p o n si bilit y t o r e gi st er t h e tri al i n a n a c c e pt a bl e 
r e gi str y, s o t h e r e s e ar c h r e s ult s m a y b e c o n si d er e d f or p u bli c ati o n i n I C M J E m e m b er j o ur n al s. T h e I C M J E 
d o e s n ot r e vi e w s p e cifi c st u di e s t o d et er mi n e w h et h er r e gi str ati o n i s n e c e s s ar y; i n st e a d, t h e c o m mitt e e 
r e c o m m e n d s t h at r e s e ar c h er s w h o h a v e q u e sti o n s a b o ut t h e n e e d t o r e gi st er err o n t h e si d e of r e gi str ati o n or 
c o n s ult t h e e dit ori al offi c e of t h e j o ur n al i n w hi c h t h e y wi s h t o p u bli s h.  
F D A A A m a n d at e s t h at a "r e s p o n si bl e p art y" (i. e., t h e s p o n s or or d e si g n at e d pri n ci p al i n v e sti g at or) r e gi st er a n d 
r e p ort r e s ult s of c ert ai n " a p pli c a bl e cli ni c al tri al s". NI H gr a nt e e s, s u c h a s t h e PI, will t a k e s p e cifi c st e p s t o e n s ur e 
c o m pli a n c e wit h NI H i m pl e m e nt ati o n of F D A A A, i n cl u di n g r e gi st eri n g t h e tri al wit h cli ni c altri al s. g o v.  
1 7  St u d y Fi n a n c e s  
1 7. 1  F u n di n g S o ur c e  
T hi s st u d y i s f u n d e d t hr o u g h a gr a nt fr o m t h e N ati o n al I n stit ut e s of H e alt h, N ati o n al I n stit ut e of N ur si n g 
R e s e ar c h 1 P 2 0 N R 0 1 8 0 7 5 -0 1.  
1 7. 2  C o st s t o t h e P arti ci p a nt  
P arti ci p a nt s will n ot b e c h ar g e d f or a n y pr o c e d ur e s of t hi s st u d y.  
1 7. 3  P arti ci p a nt R ei m b ur s e m e nt s or P a y m e nt s  
T hi s p a y m e nt s y st e m r efl e ct s t h e si g nifi c a nt c o m mit m e nt a n d eff ort t h at d at a c oll e cti o n i s a nti ci p at e d t o r e q uir e 
o n t h e p art of p arti ci p a nt s. T h er ef or e, t h e g ui d eli n e s f or t h e m ar k et m o d el of p a y m e nt fr o m Di c k ert a n d Gr a d y 
will b e u s e d f or t h e r e m u n er ati o n pl a n 4 7 . T h e f u n cti o n of p a y m e nt i n t h e m ar k et m o d el i s t h at of a n i n c e nti v e 

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rather than a reward. Using this model, participants will receive a $25 gift card at enrollment, a $25 gift card 
after 6-weeks of the intervention is complete, and a $50 when they complete the study, for a total remuneration 
of $100 per participant in the form of gift cards for the 18-week commitment. Transportation cost incurred by 
the participant for required CTSI visits will be reimbursed. 
18 Study Administration 
18.1 Study Leadership 
The study team will govern the conduct of the study. The study team will be composed of the PI, three Co-
Is, a key collaborator, a biostatistician, a project coordinator, and research assistants, as listed in section 1. 
The PI will schedule monthly study team meetings. In addition, the PI will meet individually with study team. 
19 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical industry, 
is critical. Therefore, any actual conflict of interest of persons who have a role in the design, conduct, analysis, 
publication, or any aspect of this trial will be disclosed and managed. Furthermore, persons who have a 
perceived conflict of interest will be required to have such conflicts managed in a way that is appropriate to 
their participation in the trial. The study leadership in conjunction with the NIH has established policies and 
procedures for all study group members to disclose all conflicts of interest and will establish a mechanism for 
the management of all reported dualities of interest. 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Committee with a Committee-sanctioned conflict management plan that has been 
reviewed and approved by the study sponsor prior to participation in this study. All NYULMC investigators will 
follow the applicable conflict of interest policies. 
 

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7 
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Haack M, Serrador J, Cohen D, Simpson N, Meier-Ewert H, Mullington JM. Increasing sleep duration 
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Nicklas BJ, Beavers DP, Mihalko SL, Miller GD, Loeser RF, Messier SP. Relationship of Objectively-
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Page 41 
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CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. Do not disclose or use except as 
authorized in writing by the study sponsor Behavioral Intervention Template Version: 5 MAY 2017 
44. 
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Punjabi, N. et al. Sleep disordered breathing and cardiovascular disease: An outcome-based 
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enough! Chest. 2013:143, 291-294 

Study Number: 18-00707 
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Version Date: September 27, 2019 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. Do not disclose or use except as authorized in writing by the study sponsor Behavioral  
Intervention Template Version: 5 MAY 2017 
Attachment A 
Schedule of Events 
Activity 
Recruitment ≤ 
4 weeks 
Enrollment 
CTSI Visit 1 
Baseline 
Week 1 
Baseline 
Week 2 
Intervention 
Weeks 3-13 
Intervention 
Week 14 
Intervention 
Week 15 
Final Visit 
≤ 3 weeks from 
completing 
intervention 
Study team 
procedures 
 
 
 
 
 
 
 
 
Telephone Screen 
X 
 
 
 
 
 
 
 
Schedule CTSI Visits 
X 
 
 
 
 
 
X 
 
Study Consent 
 
X 
 
 
 
 
 
 
Height, Weight, and 
Neck Measurements 
 
X 
 
 
 
 
 
 
Waist Measurements 
 
X 
 
 
 
 
 
 
Blood Pressure 
 
X 
 
 
 
 
 
 
Blood Samples 
 
X as needed 
 
 
 
 
 
 
Text/email daily 
diary reminders 
as needed 
 
X 
X 
X 
X 
X 
X 
 
Weekly Intervention 
Call 
 
 
 
 
X 
X 
X 
 
Assess for AEs,  
SAEs, UPs 
 
 
 
 
X 
X 
X 
 
Fitbit wear time 
 
 
X 
X 
X 
X 
X 
 
Deliver accelerometer  
X 
 
 
X during week 
13 
 
 
 
Accelerometer wear 
time 
 
 
X 
X 
 
X 
X 
 
Pick up/drop off 
accelerometer 
 
 
 
X 
after week 2 
 
 
X 
after week 15 
 

Study Number: 18-00707 
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Version Date: September 27, 2019 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. Do not disclose or use except as authorized in writing by the study sponsor Behavioral  
Intervention Template Version: 5 MAY 2017 
Pulse oximeter 
 
 
X 
one night 
 
 
 
 
 
Pick up pulse oximeter  
 
X after one 
night of study 
recording 
 
 
 
 
 
 
Post-intervention 
Interview 
 
 
 
 
 
 
 
X 
Surveys 
 
 
 
 
 
 
 
 
CTSI 
screening and 
enrollment 
surveys 
 
 
 
 
 
 
 
 
Data Elements 
 
X 
 
 
 
 
 
 
Additional Element  
Group – Form  
Administration 
 
X 
 
 
 
 
 
 
BRICS NINR 
Demographics with race 
clarifying questions 
 
X 
 
 
 
 
 
 
BRICS NINR 
Demographics- 
Diagnosis 
 
X 
 
 
 
 
 
 
ARES 
 
X 
 
 
 
 
 
 
AUDIT 
 
X 
 
 
 
 
 
 
General Health  
Questions 
 
X 
 
 
 
 
 
 
PHQ-9 
 
X 
 
 
 
 
 
 
Baseline surveys 
 
 
 
 
 
 
 
 
Acceptability Survey 
 
 
X 
Pre- 
intervention 
 
 
 
 
X 
Post-intervention 
Composite Scale of 
Morningness 
 
 
X 
 
 
 
 
 

Study Number: 18-00707 
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Version Date: September 27, 2019 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. Do not disclose or use except as authorized in writing by the study sponsor Behavioral  
Intervention Template Version: 5 MAY 2017 
Economic Vulnerability 
Survey 
 
 
X 
 
 
 
 
 
Family Assessment  
Device- General  
Functioning Scale 
 
 
X 
 
 
 
 
 
Sleep Environment 
Survey 
 
 
X 
 
 
 
 
 
Baseline and End of  
Study Surveys 
 
 
 
 
 
 
 
 
 
36-item Short Form  
Survey (SF-36) version  
1 
 
 
X 
 
 
 
 
 
ASA24 
 
 
X 
 
 
 
X 
 
Demographic- SDOH:  
Alcohol use (AUDIT C) 
 
 
X 
 
 
 
X 
 
Demographic- SDOH: 
Tobacco use 
 
 
X 
 
 
 
X 
 
Index of Self- regulation  
 
X 
 
 
 
X 
 
SAFTEE 
 
 
X 
 
 
 
X 
 
PROMIS Depression 6a  
 
X 
 
 
 
X 
 
Weeks 1-15 Surveys 
 
 
 
 
 
 
 
 
PROMIS Fatigue  
6a morning 
 
 
X 
X 
X 
X 
X 
 
PROMIS Fatigue  
6a evening 
 
 
X 
X 
X 
X 
X 
 
Epworth Sleepiness 
Scale 
 
 
X 
X 
X 
X 
X 
 
Daily Sleep Diary 
 
 
X (daily) 
X (daily) 
X (daily) 
X (daily) 
X (daily)