Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Phase: NA
Conditions: Mild Cognitive Impairment, Insomnia
Sponsor: University of Pennsylvania

Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults with Mild 
Cognitive Impairment 
 
PI: Miranda V. McPhillips 
 
NCT04364191 
 
IRB PROTOCOL#: 832826 
 
Date of Document: March 15, 2023 

 
DATE:
15-Mar-2023
Institutional Review Board
TO:
Miranda V Mcphillips
3600 Civic Center Blvd., 9th Floor
CC:
Foo, Stephanie
Delahanty, Michelle
Philadelphia, PA 19104
Phone: 215-573-2540
(Federalwide Assurance # 00004028)
RE:
IRB PROTOCOL#: 832826
PROTOCOL TITLE:Multicomponent Behavioral Sleep Intervention for Insomnia in Older
Adults with Mild Cognitive Impairment
 
SPONSOR:
NO SPONSOR NUMBER
REVIEW BOARD: IRB #8
IRB AMENDMENT: NOTICE OF APPROVAL
Dear Dr. Mcphillips,
The documents noted below, for the above-referenced protocol, were reviewed
by the Institutional Review Board using the expedited procedure set forth in 45
CFR 46.110 and approved on 14-Mar-2023.
Consistent with the regulations set forth in 45 CFR 46.109(f), continuing
review of this research is not required. IRB approval of this protocol will not
expire and continuing review applications should not be submitted. However,
you are still required to submit modifications and reportable events to the IRB
for review.
The documents included with the application noted below are approved:
-HSERA modification submission (confirmation # dicaaaje) submitted
3/1/2023
ONGOING REQUIREMENTS:
You must obtain IRB review and approval under 45 CFR 46 if you make
any changes to the protocol, consent form, or any other study documents
subject to IRB review requirements. Implementation of any changes
cannot occur until IRB approval has been given.
Reportable event, such as serious adverse events, deviations, potential
unanticipated problems, and reports of non-compliance must be reported

to the IRB in accordance with Penn IRB SOP RR 404.
When enrolling subjects at a site covered by the University of
Pennsylvania’s IRB, a copy of the IRB approved informed consent form
with the IRB approved from/to stamp must be used unless a waiver of
written documentation of consent has been granted.
COMMITTEE APPROVALS: You are responsible for assuring and
maintaining other relevant committee approvals. This human subjects research
protocol should not commence until all relevant committee approvals have
been obtained.
If your study is funded by an external agency, please retain this letter as
documentation of the IRB’s determination regarding your proposal.
If you have any questions about the information in this letter, please contact the
IRB administrative staff. A full listing of staff members and contact
information can be found on our website: http://www.irb.upenn.edu
***This letter constitutes official University of Pennsylvania IRB
correspondence. ***

Page 1 of 26
Modiﬁcation
Basic Info
Conﬁrmation Number:
dicaaaje
Protocol Number:
832826
Created By:
MCPHILLIPS, MIRANDA V
Principal Investigator:
MCPHILLIPS, MIRANDA V
Protocol Title:
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults with Mild Cognitive Impairment
Short Title:
MBSI-I in MCI
Protocol Description:
This pilot randomized controlled trial will test a brief (4 week), tablet-based, personalized, 
multicomponent behavioral sleep intervention for insomnia (MBSI-I) in older adults with MCI, 
compared to a sleep education control. Study assessments will be performed at pre-treatment 
(baseline), post-treatment (four weeks) and at 12 weeks post treatment follow-up.
Submission Type:
Social and Biological Sciences
Application Type:
EXPEDITED Category 2 and Category 4
PennERA Protocol Status
Approved
Resubmission*
No
Are you submitting a Modiﬁcation to this protocol?*
Yes
Current Status of Study
Study Status
Closed to subject enrollment (remains active)
If study is currently in progress, please enter the following
Number of subjects enrolled at Penn since the study was initiated
27
Actual enrollment at participating centers
0
If study is closed to further enrollment, please enter the following
Number of subjects in therapy or intervention
13
Number of subjects in long-term follow-up only
0

Page 2 of 26
IRB Determination
If the change represents more than minimal risk to subjects, it must be reviewed and approved by the 
IRB at a convened meeting. For a modiﬁcation to be considered more than minimal risk, the proposed 
change would increase the risk of discomfort or decrease beneﬁt. The IRB must review and approve the 
proposed change at a convened meeting before the change can be implemented unless the change is 
necessary to eliminate an immediate hazard to the research participants. In the case of a change 
implemented to eliminate an immediate hazard to participants, the IRB will review the change to 
determine that it is consistent with ensuring the participant&prime;s continued welfare. Examples: 
Convened Board Increase in target enrollment for investigator initiated research or potential Phase I 
research Expanding inclusion or removing exclusion criteria where the new population may be at 
increased risk Revised risk information with active participants Minor risk revisions that may affect a 
subject&prime;s willingness to continue to participate Expedited Review Increase in target enrollment 
at Penn where overall enrollment target is not exceeded or potentially sponsored research Expanding 
inclusion or removing exclusion where the new population has the same expected risk as the previous, 
based on similarities of condition Revised risk information with subjects in long-term follow-up Minor 
risk revisions with no subjects enrolled to date 
Expedited Review
Modiﬁcation Summary
Please describe any required modiﬁcation to the protocol. If you are using this form to submit an 
exception or report a deviation, enter 'N/A' in the box below.
We initially planned to power the study on two primary outcomes, sleep latency and health related 
quality of life and required a sample size of 40. However, given that this is a pilot study, Covid-19 and 
other time constraints, we decided to power the study on our main primary outcome of sleep latency. 
Our new sample size requirement is 27. We would like to change our analysis plan. For continuous 
outcomes, both mixed-effects model and GEE approach provide population average estimates. Even 
though we proposed to use mixed-effects models with random slopes and random intercepts in our 
original proposal, we feel that we may run into issues with model convergence and model estimation 
especially for model with random slope due to smaller sample size. Since GEE with exchangeable 
covariance matrix is less likely to suffer from model convergence issue, we decided to change from 
mixed-model to GEE. The estimates from mixed-model with only random-intercept and GEE with 
exchangeable covariance matrix should be very similar and both of these models. For categorical 
outcomes, since mixed-model provides subject level estimate and GEE provides population averaged 
estimates changing from one to another would be answering two different questions. But our outcome is 
continuous and both approaches will provide population averaged estimate, using either mixed-effects 
model or GEE is appropriate.
Risk / Beneﬁt
Does this amendment alter the Risk/Beneﬁt proﬁle of the study?
No
Change in Consent
Has there been a change in the consent documents?
No
If YES, please choose from the options below regarding re-consenting
Deviations
Are you reporting a deviation to this protocol?*
No

Page 3 of 26
Exceptions
Are you reporting an exception to this protocol?*
No

Page 4 of 26
Protocol Details
Resubmission*
Yes
Hospital Sites
Will any research activities and/or services be conducted at a Penn Medicine afﬁliated hospital site?
No
Study Personnel
Principal Investigator
Name:
MCPHILLIPS, MIRANDA V
Dept / School / Div:
602 - Biobehavioral and Health Sciences
Campus Address
Mail Code
Address:
149 ROSE LANE 
City State Zip:
SPRINGFIELD PA 19064-0000
Phone:
484-631-5397
Fax:
-
Pager:
Email:
mvarr@nursing.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
No
Training Expiration Date:
Name of course completed :

Page 5 of 26
Study Contacts
Name:
FOO, STEPHANIE
Dept / School / Div:
602 - Biobehavioral and Health Sciences
Campus Address
Mail Code
Address:
City State Zip:
Phone:
Fax:
Pager:
Email:
sfoo@upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
02/16/2024
Name of course completed :
Good Clinical Practice: An Introduction to ICH (GCP) Guidelines
Name:
DELAHANTY, MICHELLE
Dept / School / Div:
602 - Biobehavioral and Health Sciences
Campus Address
Mail Code
Address:
City State Zip:
Phone:
Fax:
Pager:
Email:
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
02/11/2024
Name of course completed :
Penn CR: Full Onboarding: Good Clinical Practice: An Introduction to ICH GCP Guidelines (2HRS)

Page 6 of 26
Other Investigator
Name:
HODGSON, NANCY A
Dept / School / Div:
602 - Biobehavioral and Health Sciences
Campus Address
Mail Code
Address:
418 Curie Blvd.
City State Zip:
Philadelphia PA 19104-4217
Phone:
215-898-8413
Fax:
-
Pager:
Email:
hodgsonn@nursing.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
12/15/2023
Name of course completed :
Good Clinical Practice: An Introduction to ICH (GCP) Guidelines
Responsible Org (Department/School/Division):
602 - Biobehavioral and Health Sciences
Key Study Personnel
Name:
WARD, JACK
Department/School/Division:
DM-Geriatrics
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
CONI, JANI J
Department/School/Division:
DM-Geriatrics
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
09/13/2024
Name of course completed:
Penn CR: Full Onboarding: Good Clinical Practice: An Introduction to ICH GCP Guidelines (2HRS)

Page 7 of 26
Name:
GOONERATNE, NALAKA
Department/School/Division:
DM-Geriatrics
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
POR Recertiﬁcation Quiz - Full Board Review - SOM
GCP Training Completed:
Yes
Training Expiration Date:
01/21/2024
Name of course completed:
Good Clinical Practice (GCP) for the Experienced Investigator - OCR
Name:
CHANDAKA, ASHA
Department/School/Division:
DM-Geriatrics
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
09/12/2024
Name of course completed:
CITI Good Clinical Practice (GCP) - OCR
Name:
PACK, ALLAN I
Department/School/Division:
DM-Sleep Medicine
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
POR Recertiﬁcation Quiz - Full Board Review - SOM
GCP Training Completed:
Yes
Training Expiration Date:
05/19/2025
Name of course completed:
CITI Good Clinical Practice (GCP) - OCR
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania?
No
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes

Page 8 of 26
Social and Biological Sciences
Study Instruments
Discuss the particulars of the research instruments, questionnaires and other evaluation instruments in 
detail. Provide validation documentation and or procedures to be used to validate instruments. For well 
know and generally accepted test instruments the detail here can be brief. More detail may be required 
for a novel or new instrument. For ethnographic studies identify any study instruments to be used (i.e. 
for deception studies) and describe in detail where, when and how the study will be conducted and who 
or what are the subjects of study. Note: For more information on how to conduct ethical and valid 
ethnographic research, follow the link For oral histories or interviews provide the general framework 
for questioning and means of data collection. If interviews or groups settings are to be audio taped or 
video taped describe in detail the conditions under which it will take place. Include a copy of any novel 
or new test instruments with the IRB submission. 
Sleep Measures: Consensus Sleep Diary (electronic version). We will derive sleep latency, wake after 
sleep onset, sleep efﬁciency, total sleep time, and daytime napping; Actigraphy will be used objectively 
assess various variables such as leep latency, wake after sleep onset, sleep efﬁciency, total sleep time, 
and daytime inactivity; Insomnia Severity Index (ISI),a widely used measure of insomnia; Pittsburgh 
Sleep Quality Index (PSQI), a widely used measure of sleep quality; Epworth Sleepiness Scale, a 
widely used measure of daytime sleepiness; Pre-sleep Arousal Index, this measure has been shown to 
change with relaxation and mindfulness training based on prior work performed by Dr. Gooneratne; 
Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16), a validated instrument to assess 
maladaptive beliefs regarding sleep that exacerbate insomnia, and has been shown to improve with 
insomnia treatment; the 16-item version will be used as it has more favorable psychometric properties 
than the 30-item or 10-item versions. Quality of Life: RAND Medical Outcomes Study Short Form-36 
(SF-36), one of the most widely used health-related quality of life measures, frequently used to measure 
HRQOL in older adults. It is a multidomain that measures physical and mental components of HRQOL 
with eight subscales. The 8 subscales contribute to two resulting component summaries: a mental 
component summary (MCS) and a physical component summary (PCS). Both PCS and MCS scores 
range from 0 to 100, representing worst to best health. Higher scores indicate better HRQOL. Global 
Activity: Pleasant Events Schedule; participants will rate how often they do certain activities and how 
much they enjoy it. Results will guide the tailoring of the intervention.  Physical Activity: Objective PA, 
characterized by mean level of physical activity (counts/minute), will be measured by Actigraphy. 
Subjective PA will be obtained from the Physical Activity Scale for the Elderly (PASE). Cognition: 
Telephone interview for Cognitive Status (TICS). TICS is a standardized test of cognitive function that 
can be administered over the phone or in person. Participants are given a TICS Total Score which is 
associated with one of four impairment ranges: Unimpaired, Ambiguous, Mildly Impaired, and 
Moderately to Severely Impaired. TICS-M scores of 28-36, based off ranges and optimal cutpoints 
determined in various studies, will determine eligible participants. (Graff-Radford wt al., 2006; Cook et 
al., 2009; Zietemann et al., 2017; Knopman et al., 2010). Social Activity: Participation in social activity 
will be recorded in the tablet.  Systemic inﬂammatory biomarkers, including cytokines (IL-6, IL-1ß, 
TNF-) and C-reactive protein (CRP), will be assessed at baseline, post-intervention and 3 month post 
intervention follow up. These will be assayed using dried blood spots (DBS). DBS provides an easy to 
obtain, transport, and analyze blood source. (Ostler MW, Porter JH, Buton OM. Dried blood spot 
collection of health biomarkers to maximize participation in population studies. Journal of Visualized 
Experiments, 83, 50973.) Participants will be instructed to use a Lancet to prick their ﬁnger and drop 
ﬁve drops of blood onto ﬁlter paper. They will keep the ﬁlter paper with blood spots lying ﬂat and 
uncovered at room temperature to 24-48 hours to let the blood spots dry before putting in a biohazard 
bag with a dissicant. After 48 hours and until sample pick up, they will place in the refrigerator. After 
pickup, the blood sample will be labeled, transported, and stored in a -80°C freezer until ready to be 
analyzed. All four biomarkers will be stored at Laboratory of Innovative and Translational Nursing 
Research and then assayed at CHOP Translational Core Laboratory utilizing a matrix independent 
platform (Mesoscale Discovery, Rockville MD). Other information includes age, race, education, life 
style (tobacco and alcohol use, BMI), depression (15-item GDS-SF 132,133 has been validated as an 
assessment of depression, with a yes/no format that facilitates use), medication use (antidepressant, 
benzodiazepine, sleep medication), and self-reported medical conditions. This information will be 
collected via questionnaires.

Page 9 of 26
Group Modiﬁcations
Describe necessary changes that will or have been made to the study instruments for different groups.
No modiﬁcations will be made.
Method for Assigning Subjects to Groups
Describe how subjects will be randomized to groups.
The proposed study is a randomized controlled non-crossover pilot study in which 27 participants will 
be allocated in a 1:1 ratio to the MBSI-I intervention arm or an education only control arm for a 
treatment period of four weeks. Assignment by 1:1 simple randomization will occur via the 
Randomization module in REDCap. A randomization table will be designed and uploaded to the 
REDCap system, to reﬂect 1:1 simple randomization.
Administration of Surveys and/or Process
Describe the approximate time and frequency for administering surveys and/or evaluations. For surveys, 
questionnaires and evaluations presented to groups and in settings such as high schools, focus group 
sessions or community treatment centers explain how the process will be administered and who will 
oversee the process. For instance, discuss the potential issues of having teachers and other school 
personnel administer instruments to minors who are students especially if the content is sensitive in 
nature. Describe the procedure for audio and videotaping individual interviews and/or focus groups and 
the storage of the tapes. For instance, if audio tape recording is to be used in a classroom setting, 
describe how this will be managed if individuals in the class are not participating in the study. Explain 
if the research involves the review of records (including public databases or registries) with identiﬁable 
private information. If so, describe the type of information gathered from the records and if identiﬁers 
will be collected and retained with the data after it is retrieved. Describe the kinds of identiﬁers to be 
obtained, (i.e. names, social security numbers) and how long the identiﬁers will be retained and 
justiﬁcation for use. 
Baseline (pre-treatment) assessments, collected at Visit 1, subjective sleep measures and measures of 
health related quality of life, physical activity, cognition, social activity, and blood samples.  
Intervention: A 4-week intervention (see intervention description below) will be provided to 
participants randomized to the intervention group. Sleep diaries will be completed and Actigraphs worn 
for all four weeks of treatment, in both groups.  Post-intervention and Follow-up data collection (visit 2 
week 5; visit 3 week 16): All baseline assessments will be repeated immediately post- intervention and 
at three months post-intervention follow-up (sleep measures and measures of health related quality of 
life, physical activity, cognition, social activity, and blood samples; one week sleep diary + actigraphy).  
Data on demographics and other information (age, race, education, life style (tobacco and alcohol use, 
BMI), depression, medication use (antidepressant, benzodiazepine, sleep medication), and self-reported 
medical conditions will be assessed by questionnaires at baseline, post-intervention and follow-up. All 
source documents (questionnaires) will be collected directly from the patient using the secure web 
portal that will be developed for this study. This data will be stored in the electronic clinical trials 
software application, REDCap. This application is compliant with FDA guidelines for clinical trials 
software (e.g. data encryption, electronic signatures, and internal audit trail capabilities). The 
application and data are stored on HIPAA compliant servers. The REDCap application also can manage 
study logistics to ensure timely scheduling of study visits, supports double-data entry procedures, and 
robust data analysis features to monitor study participant recruitment and retention rates.  Physiologic 
data, such as the accelerometer data, will be uploaded, in a de-identiﬁed form (no personal identiﬁers 
except for an identiﬁcation number), to the Actiware software on a password protected laptop on a 
protected server. Data collected from the tablet will be collected in de-identiﬁed form, transmitted to the 
same University of Pennsylvania servers, where it will be stored and backed-up.  Sleep diaries will be 
completed by the participants via tablet using MyCap, a feature of REDCap. No audio or video 
recordings will be made.
Data Management
Describe how and who manages conﬁdential data, including how and where it will be stored and 
analyzed. For instance, describe if paper or electronic report forms will be used, how corrections to the 
report form will be made, how data will be entered into any database, and the person(s) responsible for 
creating and maintaining the research database. Describe the use of pseudonyms, code numbers and 
how listing of such identiﬁers will be kept separate from the research data. 
We will apply strict procedures to maintain conﬁdentiality and will adhere to 2003 HIPAA Standards 
for Privacy of Individually Identiﬁable Health Information (the Privacy Rule). Each individual 
participant will be given a unique study identiﬁcation number in REDCap. Information linking the 

Page 10 of 26
identiﬁcation number to the participant will be stored on the HIPAA compliant servers (see more below 
regarding REDCap). REDCap project access will only be granted to the research team who had been 
approved by this IRB. All project records not included in REDCap will reﬂect only the ID number of 
each participant. Thus, research study participants names will not appear on any forms, and instead 
participants will use a unique identiﬁcation number.  The REDCap (Research Electronic Data Capture) 
system will be used as a central resource for quantitative data processing and management. REDCap is 
a web application and back-end database model designed to support data capture for research studies. 
The University of Pennsylvania has licensed its own version of REDCap that is housed on our own 
password-protected servers located within a data center inside the Penn ﬁrewall and therefore afforded 
the same network protections as other sensitive clinical systems. REDCap was developed speciﬁcally 
around HIPAA-security guidelines with features such as data encryption. It provides an intuitive 
interface for data entry with data validation, audit trails for tracking data manipulation and export 
procedures, automated export procedures for seamless data downloads to common statistical packages, 
including SAS, and procedures for importing data from external sources. We will use standard 
operating procedures to guide all data management activities, such as the naming and identiﬁcation of 
variables, data cleaning and handling of missing data. All data obtained from self-report measures will 
be entered directly into the REDCap database on encrypted laptop computers as collected to reduce 
data collection time, increase accuracy, and prevent data loss. Data entry screens will be designed to 
incorporate range checks and concurrent checks to minimize errors. Missing ﬁelds will not be allowed.  
We will be using the Ditti application, rather than the mPhenomic platform. The new application is 
easier to use for older adults. The application does not collect personal identiﬁable information. Each 
user is assigned a randomized user ID that is only linked to the participant in REDCap. The app does 
not collect or provide any medical data. The only data collected from the app includes randomly 
generated ID for each ID, tap timestamps, and timestamps of when the app was opened. Again, there is 
no PHI or any way to link the participant to the data from the application.
Radiation Exposure*
Are research subjects receiving any radiation exposure solely because they are enrolled in this protocol? 
(e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, FDG, Tc-99m, etc.)?IF YES, the protocol must be 
approved by the RRSC (Radiation Research Safety Committee). Consult EHRS web site: 
www.ehrs.upenn.edu/protocols/radiohuman.html for more information.If you have questions, email 
jjesik@ehrs.upenn.edu or kavyap@upenn.eduIf your protocol includes Nuclear Medicine Procedures, 
the protocol must be reviewed by the Nuclear Med Operations Committee: https://redcap.link/NMOPS
No
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)? IF YES, consult the EHRS web site: www.ehrs.upenn.edu/programs/
bio/bbpathogens.html for information on OSHA Bloodborne Pathogens requirements (training, 
vaccination, work practices and Exposure Control Plan). If you have questions, call 215-898-4453. 
Yes
Image Guided Biopsies*
Does the research involve imaging guided biopsy? IF YES, please contact the Clinical Imaging Core. 
See https://www.med.upenn.edu/cbi for more details. Any questions should be directed to the Director 
of Research Operations, Dept of Radiology, Kathleen Thomas. 
No
Computerized Tomography (CT) Studies*
Does the protocol involve CT scans that are not considered standard of care and are being performed for 
research purposes?IF YES, complete the CACTIS Committee Application: https://is.gd/CACTIS and 
consult CACTIS website: http://www.uphs.upenn.edu/radiology/research/labs/cactis/ for application 
requirements.
No
CAMRIS and MRI Studies*
Is an MRI scan being performed for research only and NOT considered standard of care (example: 
speciﬁc scanner, parameters or solely for the purposes of research)?NOTE: Research/non-standard use 
of MRI may include but is not limited to any of the following: Situations in which MRI results may 
impact subjects current clinical care plan or treatment decisions, such as:The study requires a 

Page 11 of 26
customized report with speciﬁcs regarding the study protocol (i.e., speciﬁc measurements or details); 
Introduction of a device of any kind during the MRI that is not used during a 'standard of care' type 
scan.Your MRI is not consistent with standard care time points for MRI imaging.Your MRI is not paid 
for by insurance.IF YES, consult CAMRIS website: https://www.med.upenn.edu/camris/application-
and-faq.html for application requirements and required institutional consent form language.
No
Cancer Related research not being conducted by an NCI cooperative group*
Does this protocol involve cancer-related studies in any of the following categories? Therapeutic, 
Prevention, Supportive Care, Screening, Early Detection, or Diagnostic, Epidemiologic, Observational, 
Outcome, Ancillary or Correlative. For a description of these categories, see http://www.ctsrmc.org/
submitting_a_protocol.php NCI Cooperative Groups are as follows:Alliance for Clinical Trials in 
OncologyNCI Clinical Trials Group (Canadian Cancer Society) (NCCTG)Children's Oncology Group 
(COG)NRG Oncology GroupECOG-ACRIN Cancer Research GroupSouthwest Oncology Group 
(SWOG) IF YES, the protocol must be submitted to the Cancer Center's Clinical Trials Scientiﬁc 
Review Committee for scientiﬁc review and approval prior to obtaining IRB approval. Consult the 
CTSRMC website: www.ctsrmc.org for application requirements 
No
HIPAA / Protected Health Information
Does the research proposal involve accessing (viewing / using), collecting, or disclosing of protected 
health information (PHI) directly from participants or their medical or dental record for research 
purposes?
Yes
CHPS Resources*
Does the research involve CHPS resources?
No
HUP Inpatient Nursing Resources
Does this research include an inpatient admission at HUP?
No
If the answer is YES, indicate which items is is provided with this submission:
Modiﬁed research informed consent document that incorporates HIPAA requirements
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures , whether considered routine care or strictly for research purposes? (UPHS includes all Penn 
hospitals and clinical practices, including the Clinical Care Associates network of community 
practices). Examples of UPHS services/tests/procedures includes the Clinical Translational Research 
Center (CTRC), laboratory tests, use of the pathology lab, cardiovascular imaging tests or radiology 
imaging tests (whether being billed via the Service Center or through UPHS), other diagnostic tests & 
procedures and associated professional services, etc. 
No
Veteran's Affairs (VA) Patients or Subjects
Does your study involve data from Veteran's Affairs (VA) patients or subjects?
No
If yes, was this approved by the Philadelphia VA?
No
Out of State Research
Will any Penn personnel conduct any research activities outside of the State of Pennsylvania?
No
Research involving Virtua Health
Will any Penn personnel conduct any research activities at a Virtua Health site location, OR in 

Page 12 of 26
collaboration with Virtua Health System personnel, OR using any Virtua Health System resources (e.g., 
medical records)?
No
Primary Focus*
Clinical Trial (prospectively assigning subjects to health-related interventions to evaluate outcomes)
Protocol Interventions
x Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
Survey instrument
None of the above
The following documents are currently attached to this item:
There are no documents attached for this item.
Sponsors
Business Administrator
Name:
LIU, CHIU-FANG
Dept / School / Div:
631 - Ofﬁce of Nursing Research
Phone:
215-898-8413
Fax:
-
Pager:
Email:
chiufang@nursing.upenn.edu
Department budget code
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Funding Sponsors
Funding sponsors billing address
If you have selected a commercial or industry sponsor, please provide the appropriate address and 
contact information for the Sponsor for the purposes of billing for IRB review fees (initial review, 
continuing review and convened modiﬁcation fees apply here). If the Sponsor is not industry/
commercial, this information is not necessary to provide with your application.
Funding sponsors gift
Is this research being funded by a philanthropic gift?
Regulatory Sponsor
IND Sponsor
none

Page 13 of 26
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Industry Sponsor
None
Project Funding*
Is this project funded by or associated with a grant or contract?
Yes
Selected Proposals
Proposal No
Title
10067882-01
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults with Mild Cognitive Impa
Sponsor Funding
Is this study funded by an industry sponsor?
No
Status of contract
The following documents are currently attached to this item:
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Multi-Center Research
Penn as lead
1. Is this a multi-center study where Penn is serving as the Lead Site or the Penn PI is serving as the 
Lead Investigator? 
No
Management of Information for Multi-Center Research
Penn irb of record
2. Is this a multi-center study where the Penn IRB will be asked to serve as the IRB of Record for other 
external study sites? 
No
Other Sites
No other sites
Protocol
Abstract
Insomnia symptoms in older adults with mild cognitive impairment represent a signiﬁcant public health 
burden in terms of impaired quality of life, risks from untreated insomnia, and risks from 
pharmaceutical insomnia treatment. To address the limitations in the most effective non-
pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized 
pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent 
behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. 

Page 14 of 26
The ﬁndings of the proposed project will inform future, larger scale clinical trials and may provide a 
novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and 
health-related quality of life outcomes.
Objectives
Overall objectives
1) Determine the preliminary immediate (one month) and sustained efﬁcacy (3 months) of MBSI-I 
compared to sleep education on sleep related outcomes.  2) Determine the preliminary immediate (one 
month) and sustained efﬁcacy (3 months) of MBSI-I compared to sleep education on health related 
quality of life.  3) Exploratory Aim: To explore the mechanisms by which MBSI-I affects sleep and 
health related quality of life
Primary outcome variable(s)
Sleep latency: measured at baseline, immediately post intervention (4 weeks) and 3 months post-
intervention (16 weeks). Sleep latency will be derived from subjective sleep diaries and referes to the 
time it takes a person to fall asleep, starting from the ﬁrst intention to sleep. Health-related quality of 
life, measured at baseline, immediately post intervention (4 weeks) and 3 months post-intervention (16 
weeks). Health related quality of life is a multi-dimensional concept that includes domains related to 
physical, mental, emotional and social functioning. We will use the RAND Medical Outcomes Study 
Short Form-36 (SF-36), one of the most widely used health-related quality of life measures frequently 
used to measure HRQOL in older adults. It is a multidomain that measures physical and mental 
components of HRQOL with eight subscales. The 8 subscales contribute to two resulting component 
summaries, a mental component summary (MCS) and a physical component summary (PCS). Both 
PCS and MCS scores range from 0 to 100, representing worst to best health. Higher scores indicate 
better HRQOL.
Secondary outcome variable(s)
Additional sleep outcomes include wake after sleep onset, total sleep time, sleep efﬁciency, sleep 
quality and insomnia symptoms, measured with Actigraphy, sleep diary and other validated sleep 
questionnaires. These variables are measured at baseline, immediately post intervention (4 weeks) and 3 
months post-intervention (16 weeks). We will explore the mechanisms by which the intervention affects 
sleep and health related quality of life measures via standardized questionnaires and inﬂammatory 
biomarkers.
Background
Healthy sleep is critical for optimizing health related quality of life, including physical, social, 
emotional, and cognitive domains while untreated sleep disturbances can result in physical, 
psychological, social, and economical impairments. Insomnia is the most common sleep disturbance in 
older adults and is characterized by difﬁculty initiating or maintaining sleep, awakening too early, and 
next day consequences such as difﬁculty concentrating. Epidemiological studies of older adults have 
reported insomnia prevalence of 10-40%;8 yet, less than 15% of patients with insomnia consult a 
healthcare provider or receive treatment. Furthermore, it is estimated that 7% to 20% of older adults 
have mild cognitive impairment (MCI) and 60% of people with MCI have some sleep disturbances. 
MCI is a degenerative condition characterized by cognitive decline; insomnia symptoms are 
bidirectionally linked to cognitive decline. Insomnia is often managed with pharmacologic agents 
which can be associated with adverse medical complications; memory impairments make treating 
insomnia even more challenging. Cognitive behavioral therapy is the most widely used 
nonpharmacological treatment for insomnia and although efﬁcacious in older adults has potential 
challenges in people with MCI. Thus, it is critical to develop and test interventions that are brief and 
accessible to improve insomnia in this growing at-risk population.
Study Design
Phase*
Phase I
Design
The proposed study is a randomized controlled non-crossover pilot study in which 40 subjects will be 
allocated in a 1 to 1 ratio to the MBSI-I intervention arm or an education only control arm for a 

Page 15 of 26
treatment period of four weeks. All study consents and education regarding the intervention will take 
place via telephone and video-conferencing calls. Questionnaires will be completed via REDCap.
Study duration
The new, updated study protocol will be conducted over a two year period; the ﬁrst few months have 
been devoted to establishing study databases, study operating procedures (SOP) and other logistic study 
initiation steps related to the Covid-19 protocol changes. Subject recruitment will begin in month four 
and continue during year 2, concluding in month 10 of year 3 (a total of two and a half years of subject 
recruitment, which is adequate to enroll 27 subjects). The ﬁnal 3 months of year 3 will be devoted to 
data analysis and manuscript writing. The project will begin once we have IRB approval. Participants 
will be in the study for a total of 17 weeks, including baseline visit, intervention, post-intervention and 
three month follow-up.
Resources necessary for human research protection
Describe research staff and justify that the staff are adequate in number and qualiﬁcations to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please conﬁrm that there are adequate facilities for 
the research.
The study team includes Dr. McPhillips, PhD, RN, faculty at the University of Pennsylvania, School of 
Nursing and her mentoring team: 1) Primary mentor: Dr. Nancy A. Hodgson, PhD, RN, FAAN (NH) is 
a Professor in the Department of Biobehavioral Health and the Anthony Buividas Endowed Term Chair 
in Gerontology at the Penn School of Nursing. She is an expert in clinical trials and the development 
and translation of biobehavioral sleep interventions to ease symptom burden for cognitively frail older 
adults and the study of the physiologic mechanism underlying the effect of behavioral interventions to 
reduce symptom distress. 2) Co-mentor: Dr. Nalaka S. Gooneratne, M.D, M.Sc. (NG) is an Associate 
Professor at the Penn School of Medicine, Division of Geriatric Medicine and the Center for Sleep and 
Respiratory Neurobiology, Associate Director of the Masters in Translational Research program, and 
Director of the mHealth mobile app development service. He is an expert in geriatric sleep research and 
mobile device technology. 3) Co-mentor: Dr. Allan Pack, MBChB, PhD, FRCP (AP) is a Professor of 
Medicine at Penn, Director of the Center for Sleep and Circadian Neurobiology (CSCN), and Chief of 
the Division of Sleep Medicine. Dr. Pack is a leader in the ﬁeld of sleep medicine and has a primary 
focus on sleep, chronobiology and biomarker research. All investigators have a certiﬁcate of completion 
for required education on the protection of human research participants and meet the NIH criteria for 
continued training in responsible conduct of research. Dr. McPhillips will oversee all research related 
activities. Stephanie Foo and Michelle Delahanty are part-time clinical research coordinators and Jack 
Ward is a part-time research assistant. All staff members have been approved in the previous 
modiﬁcation and will work under Dr. McPhillips' supervision. Staff will be responsible for developing 
and executing procedures and processes of study implementation including day-to-day operations (e.g. 
meeting coordination, meeting minutes), preparing Data/Safety monitoring reports, ongoing reports, 
database development, recruitment and retention, payments, data collection, and budget oversight. They 
will work closely with the PI to ensure that data collection is conducted on schedule.  Any research staff 
that will be directly involved in data collection will have one on one training sessions with Dr. 
McPhillips.  Dr. McPhillips has a research ofﬁce at Ralston House, with locked cabinets for storing 
secure data. The Penn School of Nursing has a secure research server for online data storage. We also 
have a secure research laptop for data collection. We are conﬁdent we have appropriate space and 
resources for conducting this study.
Characteristics of the Study Population
Target population
Older adults with insomnia and mild cognitive impairment
Subjects enrolled by Penn Researchers
40

Page 16 of 26
Subjects enrolled by Collaborating Researchers
0
Accrual
ACCESS TO THE POPULATION We plan to recruit 27 participants from three sources: 1) Division of 
Geriatric Medicine Division Ralston House clinic: There are currently 2,864 active patients, with 40% 
having mild cognitive impairment (MCI), yielding a potential 1,145 patients with MCI. We will use 
EPIC to generate a list of eligible participants coming in for clinic visits each week. Staff will introduce 
patients to the study team for further screening. This ﬁrst method of recruitment is on hold due to 
Covid-19. 2) PennSeek search of MCI and insomnia yielded 870 potential participants. After obtaining 
permission to contact from their provider and completing a telephone screening call, consent and 
research visits will be set up via telephone or video-conferencing call. 3) Recruitment will also include 
contacting participants from a recruitment database (I.e., subject registry), which contains names of 
over 1000 individuals who participated in or were not eligible for study team members' previous or on-
going studies and have indicated a willingness to be contacted for future studies. Participant 
information will be accessed via REDCap, and participants will be contacted by phone to determine 
interest and eligibility for this study.  ANALYSIS: Power calculation was done using PASS v21. We 
initially planned to power the study on two primary outcomes, sleep latency and health related quality 
of life and required a sample size of 40. However, given that this is a pilot study, Covid-19 and other 
time constraints, we decided to power the study on our main primary outcome of sleep latency. Thus, 
the study is powered to detect time averaged difference of two groups in a repeated measures design for 
the primary, continuous outcome of sleep latency using the generalized estimating equation (GEE) 
approach. To estimate the necessary sample size, we assumed equal allocation between the treatment 
and control groups. The minimum time averaged difference in sleep latency between the two groups we 
were interested in detecting was set at 4.5 minutes with a standard deviation of 4. We expect an even 
larger effect size, given the work of Cassidy-Eagle et al.42 Assuming a baseline correlation r = 0.80 
between multiple observations from the same subject over time and anticipating 20% attrition, we 
require 27 total participants in the study to achieve 80% power.
Key inclusion criteria
Must meet inclusion criteria of: 1) age 55 and older; 2) mild cognitive impairment: Telephone Interview 
for Cognitive Status (TICS) Total score with a range of 28-36 3) have subjective sleep diary evidence of 
insomnia, with an average sleep latency greater than 30 min or wakefulness after sleep onset of greater 
than 60 min during the one week pre-treatment assessment; 4) live in the community; 5) speak English 
as primary language (most of the study questionnaires only have validated English-language versions).
Key exclusion criteria
Exclusion Criteria include 1) Presence of moderate to severe cognitive impairment deﬁned as TICS 28; 
2) Visual or manual dexterity impairment that prevents them from pressing yes/no buttons, or selecting 
a number at 24 point font. 3) Current sedative-hypnotic or other sleep aid use on a regular or as needed 
schedule within the prior three months; 4) The presence of an acute medical or psychiatric condition 
(such as acute congestive heart failure at high likelihood of imminent hospitalization) which, in the 
judgement of the research team, would interfere with the subjects ability to realistically follow the study 
protocol
Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
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Page 17 of 26
Populations vulnerable to undue inﬂuence or coercion
N/A
Participant recruitment
Please describe the plan to equitably identify and recruit a diverse group of participants that is reﬂective 
of the population under study. If this is a multicenter protocol, the recruitment plan should describe the 
local (Penn) site's plan. Describe:how potential participants may be identiﬁed (review of medical 
records, Slicer Dicer, DAC reports including referrals from physician ofﬁces and clinics);who may 
approach potential participants;methods to achieve sample diversity and inclusiveness;what information 
may be presented to or discussed with them; andthe context and setting in which recruitment will 
happen.
We plan to recruit 27 participants from three sources: 1) Division of Geriatric Medicine Division 
Ralston House clinic, 2) PennSeek, 3) Recruitment Database. 1) Division of Geriatric Medicine 
Division Ralston House clinic: We will use EPIC to generate a list of eligible participants coming in for 
clinic visits each week. Staff will introduce patients to the study team for further screening.  This 
method of recruitment is on-hold due to Covid-19.  2) PennSeek: After obtaining permission to contact 
potential participants from their provider, we will contact them for a telephone screening call. 3) 
Recruitment will also include contacting participants from a recruitment database (I.e., subject registry), 
which contains names of over 1000 individuals who participated in or were not eligible for study team 
members' previous or on-going studies and have indicated a willingness to be contacted for future 
studies. Participant information will be accessed via REDCap, and participants will be contacted by 
phone to determine interest and eligibility for this study.
Recruitment Materials
Is the research team using any recruitment materials? These may include but are not limited to: phone 
call scripts, radio/video scripts, ﬂyers/brochures, internet postings, email, letters to potential 
participants, letters to patient physicians, My Penn Medicine (MPM), other direct messaging, etc. For 
guidance regarding recruitment materials, please review the IRB's guidance on Participant Recruitment 
Materials online:https://irb.upenn.edu/recruitment
No
Use of Penn Media & Social Media Services
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
No
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes
The following documents are currently attached to this item:
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
Participants will be compensated for their time completing all research related activities, with a 
maximum compensation of $200.  The compensation will be in the form of gift card, and broken down 
into three payments: 1) Payment 1: $50 at the end of Visit 1 (day 1; week 1) 2) Payment 2: $100 at the 
end of Visit 2 (post-intervention; week 5)  3) Payment 3: $50 at the end of Visit 3 (12 weeks post 
intervention; week 16)

Page 18 of 26
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)? Centeral nervous system(CNS) 
effect: the ability of a test article to enter into and potentially interact with the central nervoous system 
(brain and spinal cord). Clinical Investigation: Any experiment that involves a test article and one or 
more human subjects that either is subject to requirements for prior submission to the Food and Drug 
Adminstration (FDA) under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or is 
not subject to the requirements for prior submission to the FDA under these sections of the act, but, the 
results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an 
application for a research or marketing permit. 
No
Procedures
Study Procedures: A) Subjects: The target study population is older adults with mild cognitive 
impairment who have insomnia. B) Recruitment and Screening: We will recruit 27 eligible participants 
from three sources: 1) Division of Geriatric Medicine Division Ralston House clinic (on hold due to 
Covid), 2) PennSeek, and 3) Recruitment Database. After consent, subjects will be screened for key 
inclusion criteria. First, they must answer yes to one of the insomnia screening questions and score 
within the a 28-36 range on the TICS. Participants will be asked if it takes them longer than 30 minutes 
to fall asleep on most nights and/or if they are awake for more than 60 minutes during the nighttime 
period.  Next, they will receive (either by mail or contactless delivery to their door) actigraph device 
and a tablet to complete a sleep diary for a period of one week. Once insomnia inclusion criteria are 
conﬁrmed from the actigraph and diary data, we will contact participants by phone to schedule Visit 1 
via videoconference. C) Randomization: All retained participants will be randomly allocated (1:1) to 
either intervention or control arm. D) Baseline (pre-treatment) assessments, collected at Visit 1, include 
sleep measures and measures of health related quality of life, physical activity, cognition, social activity, 
and blood samples. E) Intervention: A 4-week intervention (see intervention description below) will be 
provided to subjects randomized to the intervention group. Sleep diaries will be completed and 
actigraph device worn for all four weeks of treatment, in both groups. F) Post-intervention and Follow-
up data collection (visit 2 week 5; visit 3 week 16): All baseline assessments will be repeated 
immediately post- intervention and at three months post-intervention follow-up (sleep measures and 
measures of health related quality of life, physical activity, cognition, social activity, and blood samples; 
one week sleep diary + actigraphy). G) Demographics: Data on demographics and other information 
(see measurement section) will be assessed by questionnaires at baseline, post-intervention and follow-
up.  Intervention: The intervention will include a meaningful activity protocol during the day and 
Assistive Relaxation Therapy at night. The personalized meaningful activity protocol will be developed 
based on the individuals factors contributing to insomnia, typical daily circadian proﬁle, functional 
status, and preference for activity. The individuals typical circadian proﬁle will be calculated from the 
one-week baseline accelerometer data using algorithms previously developed by Dr. Gooneratne (co-
mentor) and research team. The intervention will be broken into: 1) Sleep Hygiene Education, including 
content on routine, stimulus control principles, food/drink/substance intake (caffeine, alcohol, etc.), 
activity, naps, etc; 2) Meaningful Activity Modules a) Physical Activity, including content from the 
Go4Life Campaign (NIA) on endurance, strength, balance, and ﬂexibility b) Cognitive Activity 
including various cognitively stimulating games and exercises such as cross-word puzzles and c) Social 
engagement including identifying social support persons, group activities in the area and using 
technology to stay connected; 3) Assistive Relaxation Therapy (ART), a breath-based relaxation 
application that is coupled with a physical anchoring task. After reviewing baseline assessments to 
determine etiological risk factors contributing to the insomnia, each participant and the PI will construct 
their meaningful activity plan. Thus, study participants in the intervention arm will receive (1) tablet 
computer with Ditti application (for ART) and REDCap application, sleep education material, and 
meaningful activity modules; (2) Actigraph wrist watch device. They will be instructed how to use the 
tablet and encouraged to use the tablet. They will be asked to complete the daily sleep diary on the 
tablet, use the activity modules daily as pre-determined times personalized to the participant, use ART 
when they get in bed and if they awake during the night to help them with their insomnia symptoms for 
a four-week period. They will be asked to wear the actiwatch on the non-dominant wrist to monitor 
sleep/wake patterns. Participants will have weekly to biweekly phone consultation with the study 
interventionist to receive guidance and adjustment on activity plans. Based on previous research, 

Page 19 of 26
physical, social, or cognitive activity has shown signiﬁcant improvement in sleep in 2-4 weeks and ART 
therapy has improved sleep latency in just two weeks. Thus, we feel conﬁdent that a 4 week 
intervention period is sufﬁcient and justiﬁed.  As per NIH guidelines, we are providing additional 
details related to the intervention relevant for assessing Human Subjects Safety. The following 
components which will be used for the four-week intervention period. Tablet computer connected by 
wireless cellular phone data.  Tablet-enabled sleep diary: The Sleep Diary will be administered via the 
REDCap, utilizing the MyCap feature.  Sleep Education Information: Sleep education/sleep hygiene 
information will be loaded to the tablet; participants will also receive a print copy.  Meaningful Activity 
Modules: There will be three modules related to physical, social and cognitive stimulating activity. 
These will be loaded to the tablet; participants will also receive a print copy. Assisted Relaxation 
Therapy (ART) will be loaded onto the tablet via Ditti application. We will ask the study participant to 
engage in an anchoring task (ﬁnger tap) on the tablet screen at the exhalation point of the breathing 
cycle while they are lying in bed trying to sleep. Study participants will be asked to use the ART 
intervention every night as they are trying to fall asleep, or when they wake up at night. They will use it 
every night for four weeks. For ART intervention to work, it must be used on a nightly basis when in 
bed. It will be administered via the tablet. These technologies do not constitute a medical device as per 
FDA guidance related to mobile device technologies. Actiwatch Spectrum Plus: Each participant will be 
given an Actiwatch Spectrum Plus (Koninklijke Philips, N.V.), a piezoelectric accelerometer worn on 
the non-dominant wrist. Movement data are sampled at a rate of 32 Hz, and activity counts are recorded 
in 60-second epochs. Additionally, the watch has Silicon photodiode light sensors, and a button that 
enables participants to signal when they ﬁrst try to fall asleep and when they get out of bed in the 
morning. The button can also be used to signal naps. Periods of activity and inactivity are analyzed in 
order to estimate sleep/wake status. Computer programs are used to derive levels of activity/inactivity, 
rhythm parameters and daytime naps. Wrist actigraphy monitoring has been shown to be a reliable way 
to objectively monitor sleep-wake cycles.  Control arm: The control arm will consist of sleep education 
materials. They will be asked to complete the tablet-enabled sleep diary and wear an actigraph device 
on the non-dominant wrist. See attached for protocol table.
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Deception
Does your project use deception? Deception could be considered any direct misinformation presented to 
the subject or omission of key information pertaining to the design or nature of the project. 
No
International Research
Are you conducting research outside of the United States? 
No
Analysis Plan
Power Analysis for Sample Size described previously under "Accrual". Descriptive statistics will be 
used to characterize the sample, with measures of central tendency and variation for continuous 
measures, and frequencies and percentages for dichotomous and categorical variables. Descriptive 
estimates will be generated for all participants at each of the observed time points, and by intervention 
group within each time point. Distributional assumptions and outliers will be assessed via graphical 
approaches. Baseline characteristics between groups will be compared appropriate two sample -test or 
non-parametric Wilcoxon Rank Sum test for continuous variables and Chi-square test for categorical 
variables. Primary analysis will be carried out under the intent to treat (ITT) framework. To evaluate the 
difference between groups in our primary outcome, we will utilize the GEE model with time, group, 
and group by time as the primary predictors. A simple exchangeable correlation structure will be used 
to model the correlation between multiple observations from the same subject. Given that GEE is less 
likely to suffer from model convergence, we changed our initial approach from mixed-model to GEE. 
GEE analysis does not require complete data over time and all available data from all subjects will be 
used in estimation. We have assumed 20% missingness in our sample size estimation. For missingness 
more than 20% we will explore imputing missing values when feasible. Given the real time data 
transmission and ability to call participants and remind them to complete sleep diary, we do not 
anticipate a great deal of missing data. We will report end of study effect sizes along with p-values and 
parameter estimates. We will construct reference cell contrasts to evaluate change relative to baseline 

Page 20 of 26
and consecutive time comparisons will be conducted by proﬁle contrasts. It is reasonable to assume due 
to our sample size GEE models may fail to converge. In such situations we will obtain difference in 
score between two time points and conduct two sample t-test or Wilcoxon Rank Sum test for two 
groups comparisons. We will adjust our type I error rate to adjust for multiple comparison under this 
scenario.
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Data conﬁdentiality
Paper-based records will be kept in a secure location and only be accessible to personnel involved 
in the study.
x Computer-based ﬁles will only be made available to personnel involved in the study through the 
use of access privileges and passwords.
x Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and conﬁdentiality of identiﬁable information.
x Wherever feasible, identiﬁers will be removed from study-related information.
A Certiﬁcate of Conﬁdentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject's ﬁnancial standing, 
employability, or liability.
A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
conﬁdentiality. (This is not an option for FDA-regulated research.)
x Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys.
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identiﬁcation of subjects.
Subject Conﬁdentiality
We will apply strict procedures to maintain conﬁdentiality and will adhere to 2003 HIPAA Standards 
for Privacy of Individually Identiﬁable Health Information (the Privacy Rule). Each individual 
participant will be given a unique study identiﬁcation number in REDCap. Information linking the 
identiﬁcation number to the participant will be stored on the HIPAA compliant servers (see more below 
regarding REDCap). REDCap project access will only be granted to the research team who had been 
approved by this IRB. All project records not included in REDCap will reﬂect only the ID number of 
each participant. Thus, research study participants names will not appear on any forms, and instead 
participants will use a unique identiﬁcation number.  To ensure HIPAA compliancy, the Ditti application 
on the tablet will be password protected and users will be given a non-identiﬁable username. This 
participant username will be used (along with a password) by the subject to log onto the application; 
they will not use their e-mail or other personal identiﬁer as the username. The Ditti application or tablet 
will not store any personal health information or a participants name, birthdate, sex, home address, or 
other personal information; it will only record tap events (time-stamped). Recorded data will be 
encrypted using standard protocols at rest and in transfer, leaving no point at which the raw data will be 
openly readable until accessed by the research team. The linkage between participant ID and participant 
name can only be determined from the participants link key, which will be stored in REDCap as 
previously described. Rigorous security protocols that restrict data access points will also be 
implemented, requiring research staff to securely authenticate their identity before accessing the data. 
Access to the study participants identities will only be available to the immediate research staff. Data 
from Ditti will be abstracted and entered directly into REDCap.  Access to the study participants 
identities will only be available to the immediate research staff. The tablet app falls within the category 
of motivating patient behaviors, which according to the latest FDA guidance is considered within the 
category of enforcement discretion, therefore it does not require prior FDA review and approval. The 
app does not carry signiﬁcant risk to research study participants (it is not implanted and does not expose 
the body to signiﬁcant external energy for diagnostic or treatment purposes), thus it is within the 
category of FDA IDE device exemption. Prior research conducted by the mHealth service using similar 
exercise/behavioral intervention apps has been approved as an FDA IDE device exempt app. All data 

Page 21 of 26
will be coded with a study speciﬁc identifying number and all data will be de-identiﬁed. The identifying 
number will be kept on a password-protected, secure server as described previously. All study data will 
be transmitted using encryption, and stored on secure servers as noted previously. The majority of data 
will be collected electronically via the REDCap system and no data will be obtained on paper. 
Information will be compiled from all the participants in the study and, when published, data will be 
reported in aggregate form. As a result of aggregation, no individual participants will be identiﬁable 
from the written materials. Data will be saved for seven years and securely deleted after. The REDCap 
(Research Electronic Data Capture) system will be used as a central resource for quantitative data 
processing and management. REDCap is a web application and back-end database model designed to 
support data capture for research studies. The University of Pennsylvania has licensed its own version 
of REDCap that is housed on our own password-protected servers located within a data center inside 
the Penn ﬁrewall and therefore afforded the same network protections as other sensitive clinical 
systems. REDCap was developed speciﬁcally around HIPAA-security guidelines with features such as 
data encryption. It provides an intuitive interface for data entry with data validation, audit trails for 
tracking data manipulation and export procedures, automated export procedures for seamless data 
downloads to common statistical packages, including SAS, and procedures for importing data from 
external sources. We will use standard operating procedures to guide all data management activities, 
such as the naming and identiﬁcation of variables, data cleaning and handling of missing data. All data 
obtained from electronic medical record review and self-report measures will be entered directly into 
the REDCap database on encrypted laptop computers as collected to reduce data collection time, 
increase accuracy, and prevent data loss. Data entry screens will be designed to incorporate range 
checks and concurrent checks to minimize errors. Missing ﬁelds will not be allowed.  If tablets are lost 
or stolen, the users password can be changed on the administrative end. This will cause the account to 
automatically log-out and will require the new credentials to be input into the ﬁelds in order to access 
the Ditti user interface.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record? [NOTE: This does not apply to: 1) research information that would 
not normally be included in the electronic medical record or 2) information that is in the electronic 
medical record as part of clinical care.]
No
Subject Privacy
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas conﬁdentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy guidelines developed by relevant professions, professional associations and scholarly 
disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 
Scientiﬁc environments must be safe for both the researcher and the research subjects, and also protect 
participant privacy, conﬁdentiality, and autonomy. Research visits will take place via telephone or 
secure videoconference meeting. No meetings will be audio or video recorded.
Disclosures
Will any data or specimens from Penn participants OR other research generated work product (e.g., 
intellectual property) be disclosed to any individuals, entities, or vendors, etc. outside of Penn?
No

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Data Protection*
x Name
x Street address, city, county, precinct, zip code, and equivalent geocodes
x All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
Electronic mail addresses
Social security numbers
x Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Tissue Specimens Obtained as Part of Research*
Are Tissue Specimens being obtained for research?
Yes
Tissue Specimens - Collected during regular care*
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)?
No
Tissue Specimens - otherwise discarded*
Would specimens otherwise be discarded?
No
Tissue Specimens - publicly available*
Will tissue specimens be publicly available?
No
Tissue Specimens - Collected as part of research protocol*
Will tissue specimens be collected as part of the research protocol?
Yes
Tissue Specimens - Banking of blood, tissue etc. for future use*
Does research involve banking of blood, tissue, etc. for future use?
Yes
Genetic testing
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 

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of genetic counseling. Describe how subject conﬁdentiality will be protected Note: If no genetic testing 
is to be obtained, write: "Not applicable."
Not applicable
Consent
1. Consent Process
Overview
If participant is recruited via PennSeek, their provider will give us permission to contact them. If a 
person is recruited through the REDCap Subject Registry, they have already indicated it is okay for a 
researcher to contact them and they will be contacted directly.  In order to ensure that the participant 
truly understands what the research study entails and that his/her participation is voluntary, 
electronically signed informed consent (HIPAA authorization will be included in the informed consent 
document) will be obtained from all patients by the research team. The researcher will go over the 
informed consent document with each subject by phone and participants will e-sign using REDCap. 
Potential participants will be fully informed regarding the intensity and length of data collection 
required of them. The speciﬁc types and methods of data to be collected will be described in detail. The 
informed consent will include disclosure of the purpose and duration of the study, risks and beneﬁts, 
alternatives to participating, conﬁdentiality, and contact information for the principal investigator in 
case further questions arise. The participants will be made aware that the research study is voluntary, 
and if they choose not to be in the study or to be in the study but to stop at a later date, there will be no 
penalty or loss of beneﬁts to which they are entitled. This will help to address any role conﬂict or 
coercion, so the participant does not feel he/she has to participate in the study or will otherwise lose the 
beneﬁts of the University of Pennsylvania Health System. Participants will also have the opportunity to 
think about whether or not he/she would like to participate in the study. If a participant would like more 
time, they will have the opportunity to call the researcher back to set up another appointment. In order 
to ensure that the participant truly understands what the research study entails and that his/her 
participation is voluntary, participants will be asked ﬁve questions: What is the purpose of the study? 
What are the risks to the study? What are the beneﬁts of the study? How to contact me, the principle 
investigator? How to withdraw from the study? Assessing older adults capacity to provide consent is an 
important step in the informed consent process. Older adults who can verbally provide 4 out of 5 
answers correctly will be considered capable of providing their own consent. The researcher will again 
answer any questions they may have about the study. If they continue to agree to participate, then they 
will be asked to sign the last page of the consent form designating their consent to participate in the 
study. If the subject chooses to consent, he/she will be sent a signed version of their consent form; a 
copy will be saved in REDCap for the research team. For older adults who have given oral assent to 
participate in the study but cannot verbally provide 4 answers correctly (demonstrating the lack of 
cognitive ability to provide consent), they will not be included in this study for two reasons. First, there 
is no caregiver component to the intervention that would permit us to use proxy-reported informed 
consent and second, this study is looking at mild cognitively impairment people that should be able to 
give informed consent if they meet the inclusion criteria of the TICS-M.
Children and Adolescents
Not applicable
Adult Subjects Not Competent to Give Consent
All adult subjects must be competent to give informed consent.
2. Waiver of Consent
Waiver or Alteration of Informed Consent*
No Waiver Requested
Minimal Risk*
Impact on Subject Rights and Welfare*

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Waiver Essential to Research*
Additional Information to Subjects
Written Statement of Research*
No
If no written statement will be provided, please provide justiﬁciation
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt
Potential Study Risks
We do not believe there are any major risks associated with the proposed protocol. There is minimal 
risk associated with ﬁnger pricks for blood samples, physical activity, and study burden. We will 
explain associated risk to the participants. Other potential risks to participants are fatigue from data 
collection, stress in response to self-report instruments or concerns related to conﬁdentiality. In 
addition, the participant may experience discomfort from sleeping with the wrist watch device, but that 
usually subsides after the ﬁrst night. If the participant cannot tolerate the watch, he/she will be 
instructed that removal of the watch is allowed. Participant burden, speciﬁcally fatigue, is the most 
likely risk related to this study. To minimize fatigue during data collection, we chose only the most 
relevant self-report instruments. However, given that this is an older adult population with cognitive 
impairment; we will offer the participant the opportunity to take breaks. It is possible that some 
participants may become anxious or stressed during data collection because of the questions asked, the 
burden of data collection, or for other personal reasons. Stress is judged to be low likelihood because 
the instrument questions are not highly intrusive or sensitive. However, should this occur, the 
participant will be asked if they would like to terminate or delay data collection. Loss of conﬁdentiality 
is considered very low likelihood given the protections we will have in place and our experience in 
systems of protecting private information. Intervention: The study poses minimal risks to subjects 
beyond standard clinical care for insomnia. Sleep hygiene is a standard clinical recommendation for 
insomnia, and thus does not pose any additional risks to the subject beyond standard clinical care. 
Furthermore, the relaxation intervention component can reduce the risk of falls or daytime sleepiness 
associated with the standard of care treatment, conventional CBT-I. The tablet screen background is 
black for the sleep diary to avoid excessive light exposure at night, and the tablet screen is set to black 
when using the ART intervention in bed. The tablets are locked to prevent use of other applications.  
Plan to address risk: Finger prick via a Lancet for blood samples might result in occasional bruising, 
pain, or local reaction. All blood samples will be taken by the participant using precise methods 
provided to them.  Physical Activity: In very rare occasions, the subject may fall or get injured during 
physical activities. These adverse events should be minimized by using personalized physical activity 
plans, which will be developed/designed based on the subjects personal features by the PI to be most 
suitable for the subject. The activity intervention will be based on an existing NIH-funded activity 
protocol for older adults. Any occurrence of adverse events will be immediately reported to the IRB at 
the University of Pennsylvania.  Wrist watch discomfort: The subject may experience discomfort from 
sleeping with the wrist watch device, but that usually subsides after the ﬁrst night. If the subject cannot 
tolerate the watch, he/she will be instructed that removal of the watch is allowed.  Fatigue: We estimate 
screening and consent to take 30 minutes, quantitative data collection 20 minutes; instructions for 
actigraphy and sleep diary 5-10 minutes; blood samples 5 minutes. We anticipate developing the 
meaningful activity plan to take 30 minutes to one hour.  Stress: As the PI, I will be overseeing data 
collection. I am a registered nurse with a masters degree specialized in the care of older adults and a 
PhD. Thus, I am well trained to be supportive and helpful to the participants should they become 
anxious or stressed in response to survey questions. If participants do become stressed, data collection 
will be delayed to tend to the participants emotional needs. Data collection will resume if and when the 
participant is ready to proceed.

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Potential Study Beneﬁts
For society in general, the study offers beneﬁts in that it develops a new treatment option for insomnia 
in older adults with mild cognitive impairment, a group that has difﬁculty participating in traditional 
CBT-I and is at increased risk for side effects from pharmacotherapy for insomnia. In general, we feel 
that this study represents a minimal risk to participants. The treatments that they will undergo are 
similar to standard care for insomnia, thus pose minimal additional risk above standard medical care.  It 
is possible that while these study results may beneﬁt older adults in the future, participants in this study 
may not realize an immediate or direct beneﬁt from participating. It is also possible that the participants 
gain a heightened awareness of their sleep habits and patterns after completing the sleep diary. 
Additionally, those randomized to the intervention group may have beneﬁts from the intervention. As 
the study involves very little risk and there is signiﬁcant potential for beneﬁt, the risk / beneﬁt ratio is 
favorable.
Alternatives to Participation (optional)
The alternative to participation in the study is to decline participation and continue with routine clinical 
care for the study participants insomnia. Refusal to participate in the study will in no way adversely 
affect the clinical care the study participants would otherwise receive at the University of Pennsylvania 
Health System.
Data and Safety Monitoring
Trial monitoring will be done by a safety monitoring committee, which includes the PI, primary mentor 
(Dr. Hodgson) a statistician (Subhash Aryal) and an expert in the care of older adults (Lea Ann Matura). 
We will evaluate the progress of the study on a monthly basis, including periodic assessments of data 
quality (safety and integrity) and timeliness, recruitment, accrual and retention, participant risk versus 
beneﬁt, and other factors that can affect study outcome; consider factors external to the study when 
relevant information becomes available, such as scientiﬁc or therapeutic developments that may have an 
impact on the safety of the participants or the ethics of the trial; review study performance; and discuss 
the resolution of problems. Furthermore, we will monitor adverse events (AEs), including serious 
adverse events (SAEs) and unanticipated problems (UPs). An Adverse Event is any untoward medical 
occurrence in a patient or clinical investigation participant and which does not necessarily have a causal 
relationship with this treatment. Participants will be queried regarding any changes in their health and 
medications at each contact. The informed consent document will list the daytime and after hours 
contact information for the site Principal Investigator. All AE and SAE reporting will be done in 
adherence with IRB guidelines; the PI will notify the IRB within 48 hours of any serious possible or 
potentially study-related AEs. The report will include the description of the AEs and any actions taken 
by the PI. SAEs in this population include, but are not limited to death, hospitalization, evidence of 
abuse, suicidal ideation, and medical emergencies. The PI will also keep a log of all AEs. Any 
deviations related to the protocol will be reported to the IRB using a deviation form immediately upon 
the discovery of the deviation. Given the non-invasive nature of the intervention, the team does not 
anticipate AEs beyond the average rate of these events in this population. The literature in the ﬁeld will 
be continually appraised by the team. If any team member uncovers new information that would impact 
the safety of the participants or the ethics of our study, the PI and entire mentoring team will discuss the 
issues. At this time, given the low risk of the intervention, there is no plan for interim analyses or any 
stopping rules.
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt Assessment
We believe that the beneﬁts far outweigh the risks to participants in this study. We feel this study is 
minimal risk.
General Attachments
The following documents are currently attached to this item:
There are no documents attached for this item.

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