A Personalized (N-of-1) Trial for Testing the Effect of a Mind-Body Intervention (MBI) on Sleep Duration and Quality in Middle-Aged Women Working in Healthcare
Phase: PHASE2
Conditions: Sleep Insufficiency
Sponsor: Northwell Health

 
 
Protocol Number: 22-0770 
Version Date: 1/26/2024                           Page 1 of 32 
Official Title: 
A Personalized Trial for Testing the Effects of a Mind-Body Intervention (MBI) on Sleep 
Duration and Quality in Middle-Aged Women Working in Health Care 
 
NCT Number: NCT05789212 
 
Version Date: 1/26/2024 
 

 
 
Protocol Number: 22-0770 
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RESEARCH PROTOCOL 
 
 
Protocol Title: 
A Personalized Trial for Testing the Effects of a Mind-Body 
Intervention (MBI) on Sleep Duration and Quality in Middle-Aged 
Women Working in Health Care 
Principal Investigator: 
Karina W. Davidson, PhD, MASc 
Primary Contact Name: 
 Challace Pahlevan-Ibrekic, MBE, CIP   
Primary Contact Phone: 
347-751-2306 
 
Primary Contact E-mail: 
  cpahlevanibr@northwell.edu 
Date Revised: 
1/26/24 
IRB Number: 
22-0770 
 
 
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• Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
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form. 
 
 

 
 
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 Continue to next page to begin entering information about this study  
 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 No  
 Yes −  if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
• The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
• It should contain a clear statement of the rationale and hypothesis of your study, a 
concise description of the methodology, with an emphasis on what will happen to the 
subjects, and a discussion of the results.  
• This section should be ½ page 
 
 
This pilot study will utilize a Personalized Trials model to evaluate an individual 
participant’s experience with a Mind-Body Intervention (MBI) strategy for self-
reported perceived stress and short sleep duration of at least 3 months duration. 
Components of the MBI include mindfulness, yoga and guided walking, each 
assigned in 2-week block sequences for a total period of 12 weeks. MBI 
components will be delivered via 30-minute videos and will be accessed three 
times per week. Participants will be sent a Fitbit device to track their sleep and 
activity. Participants will be asked several questions a day sent via text message 
about their sleep quality, as well as bi-weekly questions about their health 
including stress, fatigue, concentration, confidence, mood, and pain levels to 
demonstrate relevant secondary impacts of sleep quality. Stress, anxiety and 
depression will be measured using validated assessments. Following 12 weeks of 
intervention, participants will continue to have their sleep duration monitored for a 
two-week follow-up period. After the end of the 16-week trial, participants will 
receive a summary of their observed data in a personalized report.  
 
Results from this pilot study will inform the future development of N-of-1 
methodology in the research and clinical space aimed at addressing the health and 
wellness needs of adults biologically assigned female at birth who are 40-60 years 
of age. 
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 

 
 
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• Describe and provide the results of previous work by yourself or others, including 
animal studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies 
involving the compound or device to be studied.  
• Include information as to why you are conducting the study and how the study differs 
from what has been previously researched, including what the knowledge gaps are. 
• Describe the importance of the knowledge expected to result 
 
This project represents a pilot project under the funding umbrella of the NIA-
funded grant establishing the Roybal Center for Personalized Trials at Northwell 
Health. The Center’s mission is to test use cases appropriate for N-of-1 
methodology and develop promising, innovative behavioral interventions along the 
NIH Stage model pathway, with a focus on addressing the health and wellness 
needs of an aging population. 
 
 Right now, clinicians are engaging in clinical encounters in which they are trying 
to determine the best therapy for individual patients. These encounters are likely to 
be unsuccessful. Clinicians rely on the best available evidence (e.g., results from 
parallel group, phase III randomized clinical trials; RCTs) for recommending 
therapies to a patient. Yet, conventional, between-group RCTs only provide 
estimates of the effect of therapies on the hypothetical ‘average’ patient in those 
trials. Individual patients, however, often respond differently than the hypothetical 
average patient in the phase III RCTs, and thus, heterogeneity of therapy response 
plagues clinical decisions made for an individual patient every day.   
 
The most scientifically rigorous — and potentially transformative — method for 
determining optimal therapy for a patient is a single-patient (N-of-1) trial. N-of-1 
trials are multiple crossover trials, usually randomized, and often masked, 
conducted within a single patient, with data collected objectively, continuously, 
and in the real-world, for a sufficient time period to determine whether the therapy 
is optimal for a particular patient. In many ways, Personalized or N-of-1 Trials are 
the foundational design for a truly patient-centered approach by serving as a 
clinical decision tool for patients. Historically, in introducing evidence-based 
medicine, Guyatt and others have described Personalized Trials as the pinnacle of 
the evidence-based design pyramid1.  Clinicians can use these techniques to 
monitor and make treatment decisions in chronically ill patients2, of whom 25% 
experience adverse treatment effects3. Personalized Trials are specifically designed 
to help patients and their clinicians make healthcare decisions that are informed by 
high-integrity, evidence-based information uniquely relevant to the outcomes and 
values important to them4. In post-mortem assessments as to why Personalized 
Trials had yet to become commonly employed, proponents concluded that they 
were insufficiently appealing to patients or clinicians to justify the cost and effort 
needed to design and implement them,5,6. Specifically, Personalized Trial design 
specifications had mostly been driven by clinicians or researchers 7,8, with little 
input from patients.  
 
Rationale for Selecting Sleep Duration as a Personalized Trial 

 
 
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    Sleep is an important and complex physiological process for maintaining optimal 
health. The National Sleep Foundation recommends ≥7h of sleep per night on a 
regular basis for adults aged 18-60 years9 During the first two COVID-19 
pandemic waves, findings indicated a high prevalence of both poor sleep quality 
and moderate-severe stress in healthcare workers (HCWs) (either at the frontline or 
not)10,11, and especially amongst women12. Studies conducted in a cohort of New 
York City HCWs (80% women, >50% nurses, median age of 36 years) showed that 
during the pandemic, the rates of insomnia symptoms (e.g., short duration, poor 
quality sleep) were approximately 20% higher than rates reported in 201813, and 
revealed an association between poor sleep quality and a higher prevalence of 
psychological distress14. Thus, evidence suggests that sleep may be a target 
intervention to decrease psychological distress among HCWs. While some 
mitigation interventions (e.g., reducing workload) have been proposed to address 
stress/burnout on HCWs15 very few have focused on women in healthcare and 
specifically targeted sleep as a symptom of stress. The primary goal of this pilot 
study is to determine if a personalized trial (N-of-1) employing a Mind-Body 
Intervention (MBI) can produce a meaningful increase in sleep duration among 
women 40-60 years of age and older working at Northwell Health. N-of-1 studies 
are single-patient crossover trials, where individual patients are given candidate 
treatments in a random sequence of alternating periods to determine the most 
effective treatment for that patient. In contrast to randomized controlled trials, 
which provide evidence on a population level, N-of-1 trials provide a method to 
determine what works best for the individual directly.16,17. Up to 65 women with a 
history of short sleep duration (defined as an average <7h per 24-h period for at 
least three months)18 will be enrolled (randomized) over a period of two years. 
Participants will complete a 2-week run-in period with no intervention, for baseline 
data collection, including bi-weekly surveys and Fitbit-derived sleep and activity 
data. Those who are deemed eligible and achieve at least 80% adherence of Fitbit 
wear and survey submission will be randomized to Arm 1 (N=30) or Arm 2 
(N=30). Each arm will receive a personalized intervention comprised of three 
components: mindfulness, yoga and guided walking assigned in 2-week block 
sequences for a total period of 12 weeks. Following the intervention, all 
participants will be assessed over a 2-week follow-up period. Changes in average 
daily sleep duration will be calculated for each participant based on daily 
measurements between the run-in and each treatment period. The Fitbit devices 
will also record sleep quality components (sleep onset, sleep staging, and overall 
sleep score) and physiological factors (resting heart rate, heart rate variability 
(HRV) and activity). We will also examine the direct and indirect relationships 
between perceived stress, anxiety and depression, and sleep quality assessed 
pre, during (bi-weekly), and post MBI. 
      Participant report of poor sleep duration meets all of our criteria for selection as 
a use case as outlined in our umbrella grant: it has high public health burden; high 
heterogeneity of therapy response; multiple, evidenced-based treatments; and is 
high priority for a Personalized Trial approach as determined by previously 
interviewed clinicians and patients. A recent study of US workers found the 
prevalence of short sleep duration to be 37.6% and poor sleep quality to be 19.2%, 

 
 
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supporting the need for innovative treatments19. This instance will adapt our N-of-1 
trial platform to be able to deliver a three component Mind-Body Intervention with 
the goal of meaningfully increasing average daily sleep duration as compared with 
the baseline period.  
 
 
 
 
Rationale for MBI Intervention Components: 
The three techniques included in the personalized intervention have been shown to 
be safe and effective in addressing sleep problems and reducing stress in middle 
aged women20 . Prior studies examining the effects of mediation21, yoga22, and 
physical activity23 for stress reduction found that all three interventions were 
associated with significant reductions in self-reported measures of stress and/or 
physiological measures of stress. Each of these promising behavioral interventions 
are theorized to improve sleep quantity and quality through targeting multiple 
cognitive and emotional processes that will be tested repeatedly in this proposed 
trial. However, stress and sleep reduction interventions often have high levels of 
heterogeneity of treatment effects (HTE). This personalized trial will allow us to 
evaluate the HTE and determine which treatment will be most effective for an 
individual participant. 
    As this is a digital (virtual) intervention, the maintenance of fidelity to the 
intervention delivery is expected to be identical to that found in research settings as 
the interventions will be delivered by a secure link to videos created by our 
wellness provider, Zeel. These videos have been previously used in other studies 
conducted by our Center, such as IRB # 21-0968 “Personalized Trial of Stress 
Management”. 
 
 
 
 
 
4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
• A concise statement of the goal(s) of the current study.  
• The rationale for and specific objectives of the study.  
• The goals and the hypothesis to be tested should be stated. 
 
The goal of the Roybal Center for Personalized Trials is to focus on innovative, 
behavioral interventions aimed at promoting and improving the overall health and 
well-being of older adults through the conduct of fully powered, meaningful, 
personalized trial pilots. The goal of this project is to evaluate the effects of a 
combined Mind-Body Intervention on increasing sleep duration in middle aged 
women working in health care, and to determine which intervention component 
proved most effective for each individual participant 

 
 
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Thus, the aims of this pilot study are :  
 Primary Aim: Determine if a personalized trial testing a Mind-Body Intervention 
(MBI) can produce a meaningful increase in the average daily sleep duration 
among women 40 – 60 years of age working in healthcare.  
Exploratory Aim 1: Evaluate the effect of the MBI on sleep quality and other 
physiological factors.  
Exploratory Aim 2: Explore the role of anxiety and depression as a potential 
mediator between perceived stress and sleep quality before, during, and after the 
MBI. 
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
• Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
• Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol and their trial related duties and functions 
 
We have planned for a broad base of recruitment efforts to potentially recruit a 
diverse representation of this population.   
 
Northwell employs over 79,000 individuals with strong representation by women 
in clinical, clerical, and administrative capacities. Northwell employs more than 
19,000 nurses. National statistics report that 90.6% of nurses are women and that 
the average age of a nurse in 2021 was 52 years of age. We believe we have an 
adequate population from which to recruit up to 65 participants for this study 
 
Institute of Health System Science staff must meet certain eligibility criteria before 
assisting with this pilot study. All staff members must be listed on the IRB protocol 
submission and be up to date with trainings and attestations as required by the 
Northwell Health Human Research Protection Program. Additionally, staff will be 
required to participate in biweekly meetings with the Principal Investigator, and an 
additional weekly meeting with the Project Manager, in order to stay informed 
about the study protocol, staff duties and functions, and to answer any questions 
that come up within the group. Staff will have daily access to the Project Manager, 
Director of Clinical Research, and Principal Investigator to answer any protocol 
questions they may have outside these established weekly meetings.  
 
 
 
6.  RECRUITMENT METHODS 
• Describe the source of potential subjects 
• Describe the methods that will be used to identify potential subjects 

 
 
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• Describe any materials that will be used to recruit subjects.  A copy of any 
advertisements (flyers, radio scripts, etc.) should be submitted along with the 
protocol.  
• If monetary compensation is to be offered, this should be indicated in the protocol 
 
Since the proposed study will take place virtually, potential participants are not 
required to reside within travelling distance of Northwell Health.  
 
Potential participants will be recruited via the following avenues: 
- 
E-mail advertisement through Northwell employee communication 
channels 
- 
E-mail advertisement through existing email lists from those who have 
previously expressed interest in participation in a Personalized Trial or 
who have screen failed for other Institute-led research, but who have 
been informed their data will be retained for future research. 
- 
Online research listings, such as the Feinstein Institutes for Medical 
Research clinical trials listing (https://www.northwell.edu/clinical-trials) 
and ClinicalTrials.gov (https://www.clinicaltrials.gov/) 
- 
Recruitment posts on Northwell Health Facebook page 
- 
Electronic and social media communications serving Northwell affiliates 
- 
 
Potential participants will self-identify as having a minimum threshold of poor 
sleep duration over the last 3 months and interest in participating in a 
Personalized Trial. 
 
Participants will be able to keep their Fitbit activity tracker (value $150) as 
compensation for participation in the baseline period. Additionally, participants 
who are 80% complaint with Fitbit wear and survey responses  are eligible for a 
weekly lottery ($50 award). Adherent participants are eligible to win a 
maximum of eight times ($400) during the 14 week intervention and follow-up 
periods. Upon completion of all study activities, participants will receive a $50 
clincard. 
 
 
 
 
7.  ELIGIBILITY CRITERIA 
• Describe the characteristics of the subject population, including their anticipated 
number, age, ranges, sex, ethnic background, and health status. Identify the criteria 
for inclusion or exclusion of any subpopulation.  
• Explain the rationale for the involvement of special classes of subjects, such as 
fetuses, pregnant women, children, prisoners or other institutionalized individuals, or 
others who are likely to be vulnerable.   You cannot include these populations in your 
research, unless you indicate such in the protocol 

 
 
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• Similarly, detail exclusionary criteria: age limits, special populations (minors, 
pregnant women, decisionally impaired), use of concomitant medications, subjects 
with other diseases, severity of illness, etc. 
 
Up to 65 participants will be randomized to receive this pilot study protocol. We 
aim to recruit a diverse pool of participants with varied ethnic and racial 
backgrounds. 
 
Inclusion: 
- Age 40 – 60 years 
-  Sex assigned at birth-female 
-Northwell employee or affiliate 
- Self-reported history of short sleep duration (<7h per 24-h period) for at least 3 
months 
 -After a 2-week run-in, Fitbit verified short sleep duration, and ≥80% adherence of 
Fitbit wear and survey submission 
-Self-report of perceived stress ≥18 using the Perceived Stress Scale (PSS) 
-Owns and can regularly access a smartphone capable of receiving text messages 
-Owns and can regularly access an e-mail account 
- Willingness to wear a Fitbit device 
 
Exclusion: 
- Age < 40 or > 60 years old  
-Sex assigned at birth- male 
-Not a Northwell employee 
-No history of short sleep duration or non-adherent to the Fitbit wear and survey 
submission 
-Self report of perceived stress <18 using the Perceived Stress Scale (PSS) 
- Women who are pregnant or breastfeeding 
- Does not own or cannot regularly access a smartphone capable of receiving text 
messages 
- Does not possess or cannot regularly access an email account 
- Deemed unable to complete the study protocol as a result of cognitive 
impairment, severe medical or mental illness, or active or prior substance abuse 
- Planned surgeries within 6 months from study start date 
- Participants who have been previously told by a clinician they have mobility 
limiting health conditions and/or not to engage in walking for 30 minutes, three 
times per week or yoga 
 
Planned travel outside the United States within participant’s intervention period 
will be determined on a case-by-case basis so as not to exclude interested and able 
participants from enrolling in the study.  
 
Since this study will take place virtually, potential participants are not required to 
reside within travelling distance of Northwell Health. Therefore, the exclusion 
criteria do not preclude those living outside of New York State from passing 

 
 
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screening. Individuals who reside outside New York State will be recruited after 
there is an awareness of applicable human research protection laws that may apply 
to the research. Individuals who do not live in a reviewed state will have their 
enrollment workflow paused and may be removed from the waitlist if their state is 
reviewed in the future and provided there are no HSP laws that preclude their 
enrollment. In that instance, the protocol and/or consent form may require revision 
to meet the state of interest’s requirements. 
 
 
 
 
8.  NUMBER OF SUBJECTS 
• Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled 
(consent obtained), randomized and complete the research procedures. 
• If your study includes different cohorts, include the total number of subjects in each 
cohort. 
• If this is multisite study, include total number of subjects across all sites.   
 
Up to 1000 potential participants may be screened for study eligibility.  Up to 65 
participants will be randomized until 60 (30 participants in each arm)  complete 
research procedures with any data (Fitbit or survey) post- randomization. Eligible 
participants will be randomized (1:1) into Arm 1 or Arm 2. In Arm 1 (N=30), 
participants will receive a personalized intervention comprised of three components 
delivered in a ABCCBA sequence over a total period of 12 weeks, where A-
mindfulness, B-yoga, and C-guided walking. During each 2-weeks block, 
participants will be prompted to complete 3 x 30-minute intervention sessions 
weekly. In Arm 2 (N=30), participants will receive a personalized intervention 
comprised of the same three components delivered in a CBAABC sequence over a 
total period of 12 weeks. Prompts will be delivered weekly to Arm 2 as well. 
 
 
9. STUDY TIMELINES 
• Describe the duration of an individuals participation in the study 
• Describe the duration anticipated to enroll all study subjects 
• The estimated date of study completion 
 
The study will take place over the course of 16 weeks.  
Participants will begin the trial with a 2-week run-in period during which their 
baseline sleep duration and adherence to the Fitbit wear and survey submission will 
be assessed. Following the 2-week run-in period, participants deemed eligible and 
achieved at least 80% adherence of Fitbit wear and survey submission will be 
randomized to one of the two intervention arms. Interventions will be delivered by 
a virtual link to online videos recorded by an experienced Zeel wellness provider. 
Participants will be limited to three views of the study-provided intervention 
content each week. During the intervention participants will be asked to wear their 

 
 
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Fitbit device each day and night. They will also complete sleep diaries and have 
their physiological factors assessed using Fitbit devices each day. Participants’ 
perceived stress will be measured using the ecological momentary assessment 
(EMA); screening for anxiety and depressive symptoms will be assessed using the 
patient health questionnaire (PHQ-4), a self-report version of the Primary Care 
Evaluation of Mental Disorders (PRIME-MD)15. Both EMA and PHQ-4 will be 
evaluated pre-intervention, bi-weekly during the intervention, and post-
intervention. After 12 weeks of receiving the MBI, participants will enter the two-
week follow up period to allow for a personalized report of their observed data to 
be generated. 
 
 
 
Potential participants will have the opportunity to provide preferences of start dates 
during their enrollment process. The study team will confirm applicability of the 
chosen start dates before confirming with a participant, so that no more than 20 
potential participants will begin their baseline period on the same day and every 
baseline period begins on a Monday. Leading up to baseline start date, participants 
will receive messages from the study team with instructions preparing them for the 
study, including setting up their Fitbit devices and reminding them of their 
upcoming start date. Enrollment will be ongoing until  60 participants have been 
randomized and provide any data post-baseline. We estimate that the final 
participant will be randomized by September 30, 2023, and data collection will 
cease by January 15, 2024.  
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
This study is a minimal risk pilot whose primary objective is to assess a meaningful 
increase in the average sleep duration of women 40 – 60 years of age working in 
healthcare. 
 
 
11.  RESEARCH PROCEDURES 
• Include a detailed description of all procedures to be performed on the research 
subject and the schedule for each procedure. 

 
 
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• Include any screening procedures for eligibility and/or baseline diagnostic tests 
• Include procedures being performed to monitor subjects for safety or minimize risks 
• Include information about drug washout periods 
• If drugs or biologics are being administered provide information on dosing and route 
of administration 
• Clearly indicate which procedures are only being conducted for research purposes. 
• If any specimens will be used for this research, explain whether they are being 
collected specifically for research purposes.   
• Describe any source records that will be used to collect data about subjects 
• Indicate the data to be collected, including long term follow-up 
 
Potential participants who self-identify as having poor sleep duration (<7 hrs per 
24hrs) will be directed to a study information site with details about the pilot study. 
Those who are interested in participating in this pilot study will be directed to sign 
a HIPAA Authorization form before completing an initial screening survey 
process. The HIPAA Authorization will be electronically signed via RedCap. The 
initial screening process includes questions pertaining to inclusion and exclusion 
criteria and administration of the Perceived Stress Scale (PSS). Consenting 
coordinators will review these data and determine whether a potential participant is 
eligible to participate. Those who are eligible will receive a link to a short video 
about key details from the consent form, as well as an electronic copy of the 
consent form. Potential participants will also be given the option to set up a 30-
minute phone call with a research coordinator, where the research coordinator will 
describe the study process and offer an additional opportunity for the potential 
participant to ask any questions. After completing or opting out of the phone call, 
the potential participant will be sent a link to view and electronically sign the 
consent form in RedCap. Before being able to sign and submit the consent form, 
potential participants must demonstrate their understanding of the protocol by 
correctly answering 4 questions pertaining to the information presented in the 
consent form. 
 
This study is funded by the National Institute of Aging (NIA) and a requirement of 
funding is to collect extensive demographic data during the screening process 
(prior to consent) on eligible participants, and to report this data to the NIA 
monthly on an individual level by study ID. The intended aim of this requirement is 
to ensure that funded projects are enrolling diverse populations and that screening 
does not systematically exclude members of underrepresented groups. These 
questions have been separated out from demographic data pertinent to the study 
aims and participants are informed in both the consent and on the study document 
that they have the option to decline responding to the questions without 
jeopardizing their ability to participate in the study. 
 
Once potential participants successfully submit their signed consent form, they will 
receive an onboarding questionnaire to collect more information, including a home 
address. A Consenting Coordinator will review this information and send the 
potential participant a message which will include a confirmation of the start date 

 
 
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of their baseline period, and information about what to expect during onboarding to 
the study. They will receive an initial study kit including a Fitbit device via mail 
and will receive a copy of their electronically signed HIPAA authorization and 
consent form with a URL to view the informed consent video that they watched 
previously. 
 
 All baseline periods will begin on a Monday. The baseline period will take place 
over the course of 2 weeks. Participants will be instructed to continue treating their 
sleep quality issues as they normally would and not to participate in yoga, 
mindfulness exercises or walking bouts. 
 
Each morning, baseline participants will receive a survey asking a few questions 
about their sleep quality the previous night using a modified version of the 
Consensus Sleep Diary, as well as factors that may have contributed to any sleep 
issues  
 
During the baseline period, potential participants will be asked to wear their Fitbit 
all day and night, even while they are sleeping. Participants will be asked to 
download the Fitbit app to their smart phone. Baseline participants will be 
instructed to sync their Fitbit device by opening the Fitbit app on their phone at 
least every two days and to charge their device at least every four days.  
 
Ten days into the baseline period, a Consenting Coordinator will review individual 
adherence to Fitbit wear and survey responses. Adherence to Fitbit wear will be 
defined as recorded activity of greater than 12 hours a day, and recorded sleeping 
activity greater than 180 minutes in total. Survey adherence will be defined as 
submission of a given survey. Baseline participants who do not achieve at least 
80% adherence of Fitbit wear and survey submission during the first 10 days of the 
baseline period will be given until day 14 of the trial to obtain 80% adherence. 
Those who still do not meet 80% adherence by day 14 will be withdrawn from the 
study. Those participants who do maintain at least 80% adherence during the 
baseline period will be randomized to one of two intervention sequences in the 
pilot study. Participants who are randomized to receive intervention sequences will 
receive confirmation including their protocol timeline. Enrollment will continue 
until up to 65 participants have been randomized overall, with the goal of reaching 
60 participants who complete research procedures with any post-randomization 
data: 30 participants randomized to receive ABCCBA and 30 participants 
randomized to receive CBAABC. 
 
Each intervention sequence is made up of six 2-week periods assigning yoga, 
mindfulness or guided walking. Participants will be limited to 3 (30 minute) 
intervention sessions each week. During all intervention weeks (12 weeks total), 
participants will be asked to continue wearing their Fitbit device each day and 
night. They will continue to receive EMA surveys bi-weekly with questions about 
their health such as pain, fatigue, concentration, confidence, mood, and stress at 
that current moment, as well as a daily morning text asking them to report on their 

 
 
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sleep duration and quality the previous night, using a modified Consensus Sleep 
Diary. At the end of each intervention period on Sunday evening (every two 
weeks), participants will also receive the PHQ-4 and Perceived Stress Scale (PSS). 
A study phone number and email address will be available as part of each survey to 
contact the study team if a participant is concerned about any side effects they are 
experiencing. Participants will be instructed to contact 911 or go to the nearest 
emergency room in the event of a medical emergency.   
 
Participants may receive additional messages to those outlined above with 
important reminders about their protocol (e.g., transition to a new intervention 
period), or to remind participants to sync their data or charge their devices. We will 
send a maximum of 5 text message surveys per day during the study, as well as text 
messages of these reminders and other important study communications.   
 
In the event of an unanticipated circumstance that temporarily prevents a 
participant from completing study activities (illness, injury, death in the family, 
travel, etc.), the participant will have the option of pausing their study to resume 
once their circumstance has been positively resolved. 
 
Participants will complete remote data monitoring after they have gone through one 
baseline period (two weeks), 6 intervention periods (two weeks each), and two 
weeks of follow-up), or 16 weeks total. Alternatively, a participant may choose to 
withdraw from the study, or be withdrawn from the study by the research team. 
Upon completion of data monitoring, participants will be given instructions on how 
to un-link their Fitbit from the study account.  
  
We will compile the self-reported data from questionnaires, side effects, health 
assessments such as pain, fatigue, concentration, confidence, mood, and stress 
assessments, as well as information from the Fitbit regarding activity (steps, heart 
rate, flights climbed and intensity) and sleep (duration, estimated sleep stages, sleep 
score) for each individual participant. We will analyze this data and create a 
summary report of the participant’s observed data over the study period, in relation 
to the intervention components 
 
The participant will be sent this report in an encrypted email by our study team. 
Participants will also be sent links to several online videos explaining the terms and 
data visualizations available in their summary report. These videos will be general 
to the template report and will not contain any individual results or health 
information. 
 
After being sent their report, participants will be asked to complete a satisfaction 
survey and offered the option to participate in a virtual follow-up interview (such 
as a video call over Microsoft Teams) with a member of our study team to talk 
about their experience as a research participant in this study. Participants will be 
asked several questions about what it was like to participate in the study. 
Participants will also be asked about their opinion on Personalized Trials. All 

 
 
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interviews will be audio-recorded and transcribed via Microsoft Teams (or 
equivalent program) to ensure full capture of information provided during the 
discussion. Participants will be informed that the session will be recorded prior to 
initiating the interview. If the participant declines to be recorded, they may still 
participate in the interview and the study team will take notes of the conversation. 
Audio and transcription files will be stored securely on the PHI-approved 
SharePoint server. Data collected from the satisfaction survey and the virtual 
follow-up interview will be used to inform future Personalized Trials designed by 
the investigator. 
 
 Participants will be able to keep their Fitbit activity tracker (value $150) as 
compensation for participation.  Additionally, participants who are 80% complaint 
with Fitbit wear and survey responses  are eligible for a weekly lottery ($50 award) 
during the intervention and follow-up periods. Adherent participants may be 
selected a maximum of eight times ($400) during the 14 week intervention and 
follow-up periods. Participants who complete all study activities will receive a $50 
clincard as compensation for their participation. 
 
  
 
 
12.  STATISTICAL ANALYSIS 
• Describe how your data will be used to test the hypotheses.  
• State clearly what variables will be tested and what statistical tests will be used. 
• Include sample size calculations.  
• If this is a pilot study, state which variables will be examined for hypothesis 
generation in later studies.  
 
Sample size justification: 
The primary aim of this study is to evaluate the effect of a personalized MBI on 
increasing the average daily sleep duration in working at Northwell Health. A 
sample size of 30 participants per  arm achieve 80% power to detect a  
a minimum effect size of 0.7 expected by one of the three Aim 2 interventions. 
Calculations were based on GEE tests for repeated measures considering a total of 
28 daily measurements (4 weeks) per intervention, at a significance level of 0.05. 
The within subject standard deviation σ is anticipated to be maximum 2h, with an 
auto-regressive AR(1) base correlation of 0.95 taken at two successive timepoints. 
Estimated effect size and correlation values were derived from a previous fatigue 
study that employed similar intervention/design and collected sleep duration as 
exploratory endpoint. 
 
The randomization schedule will be set up by a member of the Institute of Health 
System Science data team and provided to the data analyst assigned to this trial.. 
Randomization will occur with a fixed seed value for the purposes of repeatability 
and auditability, and the list of participants will be split into two groups using a 

 
 
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random shuffle function that takes that seed as input. The order in which an 
individual becomes eligible for one of these  randomizations will determine the 
placement given (i.e. the first person eligible will be randomized to the intervention 
order given to participant 1 and continue sequentially). Eligibility is obtained by a 
participant maintaining at least 80% adherence of survey response, Fitbit wear ≥ 12 
hours a day 80% of days, and 80% sleep data ≥ 180 minutes available through the 
baseline run-in period. The data analyst will alert the research coordinator of the 
assigned randomization once a participant becomes eligible during the baseline 
run-in period.  As this pilot is not blinded to study coordinators, this concealed 
allocation involving the data analyst alerting the study coordinator of intervention 
assignment will be used to prevent bias by blinding the sequence up until time of 
randomization.  
 
Analytical Plan 
Primary Outcome – Mean Within-Subject Difference in daily sleep duration 
during 3 treatment periods from baseline. Participant’s sleep duration will be 
measured objectively using Fitbit  devices and by self-reported questionnaires. The 
Fitbit devices will collect information continuously that will be stored in Fitabase, a 
secure, online portal. Participant sleep activity will be aggregated by day.   
Analysis of Primary Outcome: The effect of the personalized MBI intervention on 
individual’s sleep duration will be assessed in each arm separately. Individual 
changes in the average daily sleep durations between the run-in and each treatment 
period will be reported using mean (95% confidence intervals CIs). Bland-Altman 
plots will be constructed to visualize the agreement between the Fitbit reported and 
self-reported sleep duration. The effects of treatment on sleep duration will be 
assessed using generalized estimating equations (GEE) with an unstructured 
variance-covariance matrix for measures on the same day to that night’s sleep. This 
model accounts for possible autocorrelation and linear trends between sleep 
duration across time. The GEE models will include time of day of treatment 
exposure (AM versus PM) as a covariate.  
Exploratory Aim 1 Outcomes - Mean Within-Subject Difference in daily sleep 
quality and other physiological factors during 3 treatment periods from baseline. 
This aim will explore the effects of the personalized intervention on sleep quality 
components (sleep onset, sleep staging, and overall sleep score) and physiological 
factors (breathing/resting heart rate, heart rate variability (HRV) and physical 
activity). All these measurements will be recorded and aggregated daily by the 
Fitbit device.  
Analysis of Exploratory Aim 1 Outcome: The effect of the personalized MBI 
intervention on individual’s sleep quality and physiological factors will be assessed 
in each arm separately. Individual changes in the average daily sleep quality (e.g., 
score), heart rate and daily average number of steps between the run-in and each 
treatment period will be reported using means (95% CIs. GEE models will be 
employed to test the effect of the intervention of sleep quality and physiological 
factors.  
Exploratory Aim 2 Outcomes – Mean Within-Subject Difference in perceived 
stress, anxiety and depression scores measured objectively during 3 treatment 

 
 
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periods from baseline. Participants’ perceived stress score will be measured using 
the EMA questionnaire and PSS; anxiety and depressive disorder scores will be 
assessed using the PHQ-4 questionnaire. EMA , PSS and PHQ-4 will be evaluated 
pre-intervention (run-in), bi-weekly during the intervention, and post-intervention.  
Analysis of Exploratory Aim 2 Outcomes: To explore the role of anxiety and 
depression as a potential mediator(M) between perceived stress (X) and sleep 
quality (Y)  we will employ three mixed effects regression models (Fig 2).  
 
Figure 2 Mediation Model 
 
We will estimate the (c’), the indirect effect (ab), and the total effect of perceived 
stress quality (c=ab+c’).   
 
 
 
13. SPECIMEN BANKING 
• If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have 
access to the specimens 
• List the information that will be stored with each specimen, including how specimens 
are labeled/coded 
• Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the 
information to be provided with the specimens. 
 
N/A 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
• Describe the data and specimens to be sent out or received.  As applicable, describe: 
o What information will be included in that data or associated with the 
specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
• Describe the steps that will be taken to secure the data during storage, use and 
transmission. 
 
Fitbit® 

 
 
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This pilot study uses non-NFC, Fitbit devices to remotely monitor participant 
activity and sleep. All enrolled participants will be provided with instructions to 
create a study account . The email address of the study account contains a unique 
identifier (e.g., northwellpt25). Data collected will include daily steps, floors 
climbed, activity intensity, sleep duration, and estimated minutes in sleep stages.  
The list linking this unique identifier to the participants’ name or any other 
information that could identify him/her will be maintained in REDCap with limited 
view access and controls. Coded data from Fitbit will remain stored in a Northwell-
approved drive indefinitely. 
 
 
Fitabase  
This pilot study will use Fitabase to retrieve Fitbit data from 
participants. Fitabase is a secure, online portal. The Fitbit study account provided 
to the participants will be linked to an identification number in 
the Fitabase system (e.g. FLT01). No information that could be used to identify a 
participant will be stored on Fitabase. Only the research team will have access to 
data that will be able to connect a research participant to their Fitabase ID. Data 
collected will include last sync date, battery charge status, daily steps, floors 
climbed, activity intensity, sleep duration, and estimated minutes in sleep stages. 
Additional Fitbit data (e.g., breathing rate, temperature, oxygen saturation) will be 
collected and potentially used to help explain the outcome of interest. Fitabase will 
stop tracking participant data at the trial end date selected by the research 
coordinator. As an added measure, participants will be instructed to 
remove the Fitbit study account from their device if they plan on keeping the 
Fitbit.  
 
Eligibility, Consent, and Survey Data  
Screening and consenting takes place in RedCap. Northwell security-
review approved system for collecting and storing research data, including 
PHI. The study team will have access to all data, including PHI, throughout the 
study. C Data analysis will be done by unique identifier. Coded reports will 
be given back to the study team, who will identify the document before sending to 
the participant via encrypted messaging.      
 
 
 The study team takes data confidentiality very seriously.  Data collected for this 
research will be maintained on a HIPAA-compliant Northwell-approved SQL 
database.  All members of the research team with access to identifiable and coded 
data will be trained and included on the IRB submission for approval. Regular 
meetings will take place with the PI and other members of the study team to ensure 
protocol adherence and data accuracy. Data collected for this study will be 
maintained in its original and unaltered source data state in a Northwell-approved 
SQL database on a Northwell-approved drive to store PHI indefinitely. Data 
collected under this research may be used for future research in coded format 
without additional consent as per the consent form participants sign and with 

 
 
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appropriate IRB approval as required. Any additional data that must be shared will 
be done so according to the consent form participants signed.  Only research staff 
listed within this IRB submission will have access to identifiable information. 
Anonymized data may be stored indefinitely for reference following the conclusion 
of the study.  The participant will be made aware of all data collected in the 
consenting process.     
 
This research is funded by the NIA, thus a Certificate of Confidentiality has been 
issued for this research. Certificates of Confidentiality (CoCs) protect the privacy 
of research subjects by prohibiting disclosure of identifiable, sensitive research 
information to anyone not connected to the research except when the subject 
consents or in a few other specific situations.     
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the 
HRPP website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and 
Safety Monitoring Board or Committee (DSMB/C) as part of your Data and 
Safety Monitoring Plan.   
 
Part I:  Elements of the Data and Safety Monitoring Plan 
•  Indicate who will perform the data and safety monitoring for this study.   
• Justify your choice of monitor, in terms of assessed risk to the research subject’s 
health and well being.  In studies where the monitor is independent of the study staff, 
indicate the individual’s credentials, relationship to the PI, and rationale for selection 
• List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
• Indicate the frequency at which accumulated safety and data information (items listed 
in # above) will be reviewed by the monitor (s) or the DSMB/C.   
• Where applicable, describe rules which will guide interruption or alteration of the 
study design.   
• Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity. 
• Should a temporary or permanent suspension of your study occur, in addition to the 
IRB, indicate to whom will you report the occurrence.   
 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
•  When appropriate, attach a description of the DSMB.   
• Provide the number of members and area of professional expertise.   
• Provide confirmation that the members of the board are all independent of the study. 

 
 
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Dr. Chiuzan, will be responsible for ensuring participants’ safety on a daily basis. 
As the proposed project is a Stage 2 study of the effectiveness of MBIs to achieve 
improved sleep quality, and these MBIs have been implemented with health care 
workers in other personalized trials, the level of risk appears to be that of those 
experienced in everyday life. Dr. Chiuzan, the study coordinator, and Ms. Duer-
Hefele will regularly monitor participant safety evaluate the progress of the study, 
review procedures for maintaining the confidentiality of data, review the quality of 
data collection, management, and analyses at weekly team meetings. 
 
To assure data accuracy, the Data Manager will process monthly reports to search 
for errors and generate basic reports for dissemination at regular meetings. Protocol 
compliance will be reviewed during regular meetings between Dr. Chiuzan, Ms. 
Duer- Hefele and the research team. Finally, Ms. Duer-Hefele will perform a 
random audit of 5% of enrollments, and provide continual feedback to improve the 
quality of informed consent and data collection. 
 
Dr. Chiuzan and Ms. Duer-Hefele will convene no less than monthly to 
comprehensively review participation in the study. As this is a minimal risk study, 
no safety officer has been appointed for this study. The study team will regularly 
convene to share safety reports with Dr. Chiuzan. All collected data will be stored 
in the RedCAP program, a Northwell IRB and Research IT security approved 
location, housed on the Northwell IT approved server. All data will be de-identified 
before analysis and before being made available for data sharing. Following the 
onset of data collection, the Data Manager will provide this group with biweekly 
reports of the aggregate data, progress of the study, including participant accrual, 
protocol compliance, and problems encountered. 
 
 
 
 
16. WITHDRAWAL OF SUBJECTS 
• Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
• Describe procedures for orderly termination 
• Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
Circumstances under which participants will be withdrawn from the research 
without their consent include not meeting objective verification of short sleep 
duration (<7 hrs per 24hr periods during 2 week run-in as measured by a Fitbit 
activity tracker), failure to maintain protocol adherence, and self-reported adverse 
side effects to interventions. A potential participant will not be randomized to 
receive the intervention protocol until he/she has demonstrated at least 80% 
adherence to continuous Fitbit monitoring (activity recorded > 12 hours/day, and 

 
 
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recorded sleep activity >180 minutes) and response to survey questionnaires during 
the baseline period.  
 
Potential participants will be notified of the possibility of being removed from the 
study before intervention randomization due to adherence issues in the informed 
consent. Participants who fail to maintain minimum adherence during baseline will 
be notified by the research team in the first 10-14 days of baseline participation. 
These participants will stop receiving notifications and survey prompts and will 
receive instructions to un-link their Fitbit device.  
  
Participants who fail to maintain protocol during the intervention period will be 
contacted by a member of the study team with a reminder of the study protocol and 
will be informed that this may impact their continued study eligibility. If it is 
determined that the participant will be withdrawn from the study, the participant 
will be notified of their withdrawal from the study by the research team. The 
participant will stop receiving notifications and survey prompts and will be sent 
instructions to un-link their Fitbit device. The participant will be able to keep their 
Fitbit device.  
 
Should a participant choose to withdraw from research, they will be instructed to 
send a letter or e-mail to the attention of the Principal Investigator at our 130 East 
59th Street office, or to email p30mbi@northwell.edu, an e-mail account 
monitored by IRB-approved members of the research team. Participants will be 
contacted by a member of the research team confirming their study withdrawal, and 
to answer any questions the participant may have. The participant will stop 
receiving notification and survey prompts and will be sent instructions to un-link 
their Fitbit device. They will be able to keep their Fitbit device. Data collection will 
stop the business day the letter or e-mail is received. All data up until the receipt 
date of the letter or e-mail will be included in the research study.  
 
 
 
 
17. RISKS TO SUBJECTS 
• Describe any potential risks and discomforts to the subject (physical, psychological, 
social, legal, or other) and assess their likelihood and seriousness and whether side 
effects are reversible. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects.  
• Include risks to others , like sexual partners (if appropriate) 
• Discuss why the risks to subjects are reasonable in relation to the anticipated benefits 
and in relation to the importance of the knowledge that may reasonably be expected 
to results 
• Describe the procedures for protecting against or minimizing any potential risks, 
including risks to confidentiality, and assess their likely effectiveness.   
 

 
 
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This study poses no greater than minimal risk to participants. Monitoring for 
adverse side-effects will be performed during the N-of-1 trial. Participants will be 
encouraged to adhere to the protocol but will also be told that they can discontinue 
intervention at any time.  
 
It is not uncommon for participants to experience temporary soreness and/or 
fatigue following low-intensity physical activity (walking) or stretching (yoga). 
There is always a risk that physical activity can result in musculoskeletal injury. 
Mindfulness meditation may include experiences that are pleasant, unpleasant, or 
neutral. It can lead to states of ease, joy, relaxation, peace and a sense of wellbeing. 
Unpleasant experiences such as agitation, physical discomfort, sleepiness, sadness 
and anger are also common. Such experiences are usually temporary.  
  
If participants experience discomfort during their intervention sessions, they will be 
instructed to immediately stop the activity and contact a research coordinator.  
  
There is always a risk of potential emotional distress in answering survey questions 
examining one’s stress levels. 
 
There is also the potential risk of loss of privacy of information pertaining to 
research material collected by the study. Yet, we will take precautions, described 
below, to minimize these risks.  
 
We will emphasize to subjects in the intervention arm that they can withdraw from 
the N-of-1 trial completely at any point, particularly if they experience 
any concerning side-effects. Participants will be instructed to contact 911 or go to 
the nearest emergency room in the event of a medical emergency. Adverse events 
will be reported to the PI, IRB and sponsor as outlined in the DSMP. 
 
Surveys 
Should a participant report emotional distress in responding to survey questions, 
the research coordinators will refer to Dr. Chiuzan, who is responsible for 
overseeing participants’ safety and who will recommend follow-up.  
 
Fitbit 
There is no additional risk with using a Fitbit activity monitor for research as 
compared to using the device as a consumer, including mild skin irritation (i.e. 
contact dermatitis) which occurs among a small proportion of users. Participants 
will be instructed via the consent form on methods to reduce irritation (e.g. keep 
the band clean and dry) and that they can remove the band for a short period of 
time. 
 
Loss of Confidentiality or Privacy 
All subjects will be informed that their responses are confidential and that they may 
refuse to participate in the project or withdraw at any time without explanation, 
and that such action will not affect their future interactions with their health care 

 
 
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providers, employment, educational studies, or the research study. The risk of loss 
of confidentiality will be minimized by securely storing data including PHI in a 
Northwell-approved database and minimizing the use of PHI. To ensure 
confidentiality, all data containing personal identifiers, and used to track contact 
with patients, will be kept in a secure, password-protected, encrypted Northwell-
approved database. No paper documents with personal identifiers will be kept. The 
PI will be responsible for ensuring that the confidentiality of the data is maintained 
at all times. All data will be obtained specifically for research purposes.  
  
Personal or identifiable information is not stored on any of the devices used in this 
study. No information about the participants or the participants’ health history will 
be shared with Fitbit, except for the information the participants directly share 
themselves should they choose to use the device for personal use at the conclusion 
of the study. There is no additional risk with using Fitbit as part of this research 
study as compared to using the device as a consumer.  
 
 
 
 
18. RESEARCH RELATED HARM/INJURY 
• Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated problems that may be known to be associated with the 
research. 
• If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, 
and who will pay for it.   
 
Research-related injuries are not expected for this “no greater than minimal risk” 
project.  
 
 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
• Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration 
instead of four times a day, an oral formulation over an IV administration).  
• Also state if there are no known benefits to subjects, but detail the value of knowledge 
to be gained 
 
Although not a primary endpoint, participants randomized to the intervention may 
receive an indirect benefit, i.e., they may gain a better understanding of MBI 
components impact their sleep duration, and the impact of perceived stress levels 
on their sleep duration. This may result in their being more satisfied with their 

 
 
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sleep quality wellness regimen and in achieving reduced sleep disturbance 
symptoms. Through pooling N-of-1 trial data, a greater understanding of the 
effectiveness of MBI on sleep duration. This knowledge may contribute to the 
incorporation of N-of-1 trials into the clinical practice of sleep quality 
management. Additionally, the information collected from participant involvement 
will inform the development of future personalized trials to help other research 
participants and eventually patients discover which wellness options are best for 
them as an individual. 
 
 
20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
• Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
• In addition consider privacy protections that may be needed due to communications 
with subjects (such as phone messages or mail).   
 
Names and email addresses from potential study participants will not be collected 
until they have read through web information explaining the research study and 
protocol and indicated their interest in the study. This information will be stored in 
a Northwell-approved database drive to store PHI, and it will only be accessible to 
research staff listed on the approved IRB protocol. Names or other identifying 
information will not be shared with those outside the research team, except as 
indicated in the “Data Management and Confidentiality” section above for the 
purposes of sending research communications. Phone numbers and email will only 
be used for study-related communications, and employees will be contacted outside 
the study for future research opportunities only as indicated in the consent 
document.  
 
 
 
21.  COSTS TO SUBJECTS 
 
• Describe any foreseeable costs that subjects may incur through participation in the 
research 
• Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
This research study is funded by the National Institutes for Aging (NIA). All study 
devices will be provided to participants at no cost. Participant insurance will not be 
billed. 
 
This study uses text messaging to deliver notifications, reminders, and study 
questionnaires. Standard message and data rates from the participant’s wireless 
carrier may apply to the study participant. Study participants will not be 
compensated for any costs related to data usage or sending or receiving text 
messages by the study or by members of the study team. 

 
 
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22. PAYMENT TO SUBJECTS  
 
• Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
 
Study participants who successfully complete baseline will be able to keep their 
Fitbit device (value $150).  Participants who complete all study activities will 
receive a $50 ClinCard as compensation. 
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• Who will be obtaining consent 
• Where consent will be obtained 
• Any waiting period available between informing the prospective participant and 
obtaining consent 
• Steps that will be taken to assure the participants’ understanding 
• Any tools that will be utilized during the consent process 
•   Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
• Procedures for maintaining informed consent.   
 
Consent and written authorization will be obtained electronically via REDCap 
with a copy of the electronically signed form sent to the participants with their 
study instructions and devices. Before being sent a copy of the consent form, 
potential participants will view a brief summary of the study, complete a 
written authorization form, and complete initial screening forms.   
 
If a prospective participant is deemed ineligible, or if the potential participant is 
eligible but needs to be waitlisted due to demand, the consenting coordinator 
will notify the potential participant via text within 2 business days of the initial 
completion date of the pre-screen.  
 
If the potential participant is deemed eligible, potential participants will opt in 
or out of having a 30-minute virtual call to go over study details with a 
consenting coordinator and have the opportunity to have any of their questions 
answered. After the phone call takes place, the consenting coordinator will send 
the potential participant a link to read and electronically sign the consent form. 
If the participant opts out of having the call, they will be sent a link to read and 
electronically sign the consent form. Included at the link sent to participants 
who opted in and out of the call will be a short, animated video that explains 
key aspects of the protocol and consent process. Included in these materials will 

 
 
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be contact information to reach a consenting coordinator to answer any 
additional questions they have before signing the consent form. In order for the 
consent form to be signed and submitted successfully, potential participants 
will need to correctly answer 4 questions about the protocol to demonstrate 
their understanding. PDF versions of signed consent forms will be maintained 
electronically on a HIPAA-compliant, Northwell Health-approved share drive, 
accessible only to members of the research team listed on the IRB protocol. A 
copy of the consent form and signed signature page will be sent to the potential 
participant along with their baseline study material.  
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your 
study involves children, additional information should be provided to describe: 
• How parental permission will be obtained 
• From how many parents will parental permission be obtained 
• Whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  The process used to determine 
these individual’s authority to consent for the child should be provided 
• Whether or not assent will be obtained from the child 
• How will assent be documented 
• Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the 
research.  If so, describe the process that will be used to obtain their legal 
consent to continue participation in the study.  Indicate what will occur if consent 
is not obtained from the now-adult subjects.   
 
N/A 
 
 
If the study involves cognitively impaired adults, additional information should be 
provided to describe: 
• The process to determine whether an individual is capable of consent 
• Indicate who will make this assessment 
• The plan should indicate that documentation of the determination  and 
assessment will be placed in the medical record, when applicable, in addition to 
the research record. 
• If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an 
explanation as to why not 
o Describe whether assent will be documented and the process to document 
assent 

 
 
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o Indicate if the subject could regain capacity and at what point you would 
obtain their consent for continued participation in the study 
 
N/A 
 
 
If the study will enroll non-English speaking subjects: 
• Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
• Indicate whether or not consent forms will be translated into a language other 
than English 
• Describe the process to ensure that the oral and written information provided 
to those subjects will be in that language 
• If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
 Presently we hope to collect enough information to justify that this 
methodology offers a scalable, and efficacious means of supporting sleep 
health in women who are health care workers, and that this pilot will 
provide data to support larger clinical trials designed to assess efficacy of 
the given interventions. Injustice has no place in research with human 
subjects and undermines public trust in science, thus we are committed to 
enrolling a racially and ethnically diverse population in this protocol and for 
all research conducted by the Institute for Health System Science. Towards 
that commitment, we anticipate that many participants interested in this 
current research project will represent racial and ethnic minority groups, 
and we intend to advertise the research without restriction. Race and 
ethnicity (not just English proficiency) are strongly correlated with access 
to care, environmental exposures, income, employment, and other social 
determinants of health, which, by definition, affect health outcomes. We 
will collect information on all of these factors to help inform virtual 
research delivery and do not believe that focusing on native English 
speaking participants in this pilot study - those that may be from ethnically 
and racially diverse populations -  will confirm pre-existing bias or will 
later negatively impact equitable access, participant comprehensibility or 
research design applicability to the diverse populations that may be solicited 
for participation in future clinical trials run under an N-of-1 design.   
 
 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       
          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 

 
 
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• Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk to the subject:   
• Explain why the waiver/ alteration will not adversely affect the rights and welfare 
of subjects 
• Explain why it is impracticable to conduct this research if informed consent is 
required   
• Explain why it is not possible to conduct this research without using the 
information or biospecimens in an identifiable form 
• If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 
Since the consent process will be remote and self-directed, it is not practical or 
feasible for the investigator to sign the consent form in  RedCap. As such, 
we request a waiver of the investigator’s signature for this research which is 
no greater than minimal risk.  Individuals are encouraged to reach out to the 
study team via email and/or a direct phone line if they have any questions and 
prior to signing the consent form.  
 
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they 
wish to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
• Explain how the only record linking the subject to the research would be the 
consent document. 
• Explain how the principal risk of this study would be the potential harm resulting 
from a breach in the confidentiality 
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
 
 
SUBSECTION 2 
•  Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk.   
• Confirm that the research only involves procedure for which consent is not 
normally required outside the research context.  
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
 
 
. 

 
 
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25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 
 N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  
• Describe the risks to privacy involved in this study and explain why the study 
involves no more than minimal risk to privacy:   
• Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
•  Indicate why it is not possible to seek subjects’ authorization for use or 
disclosure of PHI. 
• Indicate why it is not possible to conduct this research without use or disclosure 
of the PHI.   
• Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization 
needs to be tracked. Please see guidance at www.nslij.com/irb for information 
about tracking disclosures. 
 
 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared 
or disclosed to any other person or entity. 
• Describe how data will be collected and used:  
• Indicate why you need the PHI (e.g.PHI is required to determine eligibility, 
identifiers are necessary to contact the individual to discuss participation, other) 
• Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 
population, no treating clinician to assist in recruitment of the study population, 
other) 
 
 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, 
submit the appropriate appendix to the IRB for review: 
 
  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 

 
 
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Version Date: 1/26/2024                           Page 30 of 32 
  poor/uninsured 
  Students 
  Minorities 
  Elderly 
  Healthy Controls 
 
If any of these populations are included in the study, describe additional safeguards that 
will be used to protect their rights and welfare. 
 
This study is enrolling health care workers. Individuals with a supervisory relationship 
over an employee will not enroll any individual who reports to them in this study. 
Employee participation or non-participation in this study will have no bearing on an 
individual’s position at Northwell Health. 
 
We do not intend to prevent study personnel or other employees of the Institute of 
Health System Science who express an interest in the research from participating. 
However, no supervisory personnel will be able to enroll participants who report to 
them in this research. We are not intentionally targeting minorities but expect 
minorities to be part of those eligible for participation. 
 
 
27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management 
of information (e.g. results, new information, unanticipated problems involving risks to 
subjects or others, or protocol modifications) among sites to protect subjects. 
N/A 
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 
Provide a reasonable list of references directly related to the study. Any diagrams for 
new medical devices or brief reprints from journals might also prove useful. 
 
1.Guyatt, G.,Haynes, B., Jaeschke, R.,Cook, D.,Greenhalgh,T., Mead,M., Green, L.,Naylor, 
C.,Wilson,M., McAlister, F., & Richardson, W. (2002). Introduction: The philosophy of 
evidence-based medicine. In G. Guyatt, & D. Rennie (Eds.), Users’ Guides to the Medical 
Literature : A Manual for Eevidence-based Clinical Practice (pp. 3–11). Chicago, IL: American 
Medical Association. 
2.Ridenour TA, Pineo TZ, Maldonado-Molina MM, Hassmiller-Lich K. Toward idiographic 
research in prevention science: Demonstration of three techniques for rigorous small sample 
research. Prevention Science. 2013;14:267-78.  

 
 
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Version Date: 1/26/2024                           Page 31 of 32 
3.Gandhi TK. Adverse drug events in ambulatory care. New England Journal of Medicine. 
2003;348(16):1556-64.   
4.Duan N, Kravitz RL, Schmid CH. Single-patient (n-of-1) trials: a pragmatic clinical decision 
methodology for patient-centered comparative effectiveness research. J Clin Epidemiol. 
2013;66(8 Suppl):S21-8. 
5.Kravitz RL, Duan N, Niedzinski EJ, Hay MC, Subramanian SK, Weisner TS. What ever 
happened to N-of-1 trials? Insiders' perspectives and a look to the future. Milbank Q. 
2008;86(4):533-55.  
6.Guyatt G. N of 1 randomized trials: a commentary. J Clin Epidemiol. 2016;76:4-5.  
7.Recommended principles and practices for the provision of humanistic psychosocial 
services: Alternative to mandated practice and treatment guidelines. Humanistic Psychologist. 
2004;32(1):3-75.  
8.Gabler NB, Duan N, Vohra S, Kravitz RL. N-of-1 trials in the medical literature: a systematic 
review. Med Care. 2011;49(8):761-8. 
9. Hirshkowitz M, Whiton K, Albert SM, et al. National Sleep Foundation’s sleep time duration 
recommendations: methodology and results summary. Sleep Health. 2015;1(1):40-43. 
doi:10.1016/j.sleh.2014.12.010 
10. Jáuregui Renaud K, Cooper-Bribiesca D, Martínez-Pichardo E, et al. Acute Stress in Health 
Workers during Two Consecutive Epidemic Waves of COVID-19. Int J Environ Res Public 
Health. 2021;19(1):206. doi:10.3390/ijerph19010206 
11. Miguel‐Puga JA, Cooper‐Bribiesca D, Avelar‐Garnica FJ, et al. Burnout, depersonalization, 
and anxiety contribute to post‐traumatic stress in frontline health workers at COVID‐19 
patient care, a follow‐up study. Brain Behav. 2021;11(3). doi:10.1002/brb3.2007 
12. Sriharan A, Ratnapalan S, Tricco AC, et al. Occupational Stress, Burnout, and Depression in 
Women in Healthcare During COVID-19 Pandemic: Rapid Scoping Review. Front Glob Womens 
Health. 2020;1:596690. doi:10.3389/fgwh.2020.596690 
13. Abdalla M, Chiuzan C, Shang Y, et al. Factors Associated with Insomnia Symptoms in a 
Longitudinal Study among New York City Healthcare Workers during the COVID-19 Pandemic. 
Int J Environ Res Public Health. 2021;18(17):8970. doi:10.3390/ijerph18178970 
14. Diaz F, Cornelius T, Bramley S, et al. The association between sleep and psychological 
distress among New York City healthcare workers during the COVID-19 pandemic. J Affect 
Disord. 2022;298:618-624. doi:10.1016/j.jad.2021.10.033 
15. Correia I, Almeida AE. Organizational Justice, Professional Identification, Empathy, and 
Meaningful Work During COVID-19 Pandemic: Are They Burnout Protectors in Physicians and 
Nurses? Front Psychol. 2020;11:566139. doi:10.3389/fpsyg.2020.566139 

 
 
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16. Guyatt G, Sackett D, Taylor DW, Ghong J, Roberts R, Pugsley S. Determining Optimal 
Therapy — Randomized Trials in Individual Patients. N Engl J Med. 1986;314(14):889-892. 
doi:10.1056/NEJM198604033141406 
17. Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: the 
ultimate strategy for individualizing medicine? Pers Med. 2011;8(2):161-173. 
doi:10.2217/pme.11.7 
 
18. Consensus Conference Panel, Watson NF, Badr MS, et al. Joint Consensus Statement of 
the American Academy of Sleep Medicine and Sleep Research Society on the Recommended 
Amount of Sleep for a Healthy Adult: Methodology and Discussion. Sleep. 2015;38(8):1161-
1183. doi:10.5665/sleep.4886 
19.Yong LC, Li J, and Calvert GM. Sleep-related problems in the US working population: 
prevalence and association with shiftwork status. Occup Environ Med. 2017 Feb;74(2):93-104. 
doi: 10.1136/oemed-2016-103638. Epub 2016 Sep 8. 
 
20. Wang WL, Chen KH, Pan YC, Yang SN, Chan YY. The effect of yoga on sleep quality and 
insomnia in women with sleep problems: a systematic review and meta-analysis. BMC 
Psychiatry. 2020;20(1):195. doi:10.1186/s12888-020-02566-4 
21. Goyal M, Singh S, Sibinga EMS, et al. Meditation Programs for Psychological Stress and 
Well-being: A Systematic Review and Meta-analysis. JAMA Intern Med. 2014;174(3):357. 
doi:10.1001/jamainternmed.2013.13018 
22. Pascoe MC, Thompson DR, Ski CF. Yoga, mindfulness-based stress reduction and stress-
related physiological measures: A meta-analysis. Psychoneuroendocrinology. 2017;86:152-
168. doi:10.1016/j.psyneuen.2017.08.008 
23. Strehli I, Burns RD, Bai Y, Ziegenfuss DH, Block ME, Brusseau TA. Mind–Body Physical 
Activity Interventions and Stress-Related Physiological Markers in Educational Settings: A 
Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2020;18(1):224. 
doi:10.3390/ijerph18010224