Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older Adults
Phase: NA
Conditions: Insomnia Disorder
Sponsor: Wake Forest University Health Sciences

Official Title:  Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older 
Adults  
NCT05780983
IRB Approval Date:  05/02/2024

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Sleep Well 24 (SWELL24): 
Promoting healthy sleep-wake behaviors across a 24-hour cycle in frail older adults 
Principal Investigator: Jaime M. Hughes 
Co-Investigators: W. Jack Rejeski, Barbara Nicklas, Jason Fanning, Nick Pajewski, Gretchen 
Brenes, Heidi Klepin 
Study Coordinator: Laura Welti 
Regulatory Contact: Laura Welti 
Sponsor or funding source: National Institute on Aging/Wake Forest Pepper Center Research 
and Education Component Early Career Faculty Scholar 
Protocol Version Date: 05.02.2024 
Amended (Dates): 11.08.2023 

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Background, Rationale and Context 
Healthy sleep-wake patterns are critical in preventing disability, supporting rehabilitation, and 
preserving functional independence in older adults. However, two-thirds of older adults meet 
clinical criteria for insomnia, defined as difficulty falling or staying asleep accompanied by 
impairments in daytime function. Less than one-half of older adults with insomnia engage in 
regular exercise. In our prior work, we found frail older adults, defined as individuals with 
multiple chronic conditions, and competing cognitive and functional limitations, more commonly 
endorsed daytime consequences of poor sleep rather than nighttime symptoms. Furthermore, 
these daytime consequences prohibited older adults from participating in chronic disease 
management and/or rehabilitation activities. Evidence-based interventions exist for improving 
nighttime sleep and daytime activity behaviors; yet these behaviors are typically assessed and 
treated in isolation.  
This two-part proposal uses a sequential mixed methods design to describe sleep-wake 
behaviors across a 24-hour period (Part I, Aim 1) and finalize daytime components for initial 
evaluation in a pilot trial (Part II, Aim 2). 
Objectives 
Part I, Aim 1. To describe older adults’ sleep-wake behaviors across a 24-hour 
cycle, including association with functional status, and to explore preferences for 
treatment. Approach: Older adults utilizing WFBH primary care services who endorse poor 
sleep and low activity will participate in an in-person sleep and activity assessment examining 
sleep-wake behaviors (i.e. nighttime sleep behaviors, daytime physical activity, and sedentary 
time), functional performance status, and overall health. Daily sleep-activity diaries will explore 
the physical and social contexts in which poor sleep-wake behaviors occur. Open-ended 
assessment items will explore older adults’ perceptions of sleep-wake behaviors and 
preferences for participating in a sleep-activity behavioral intervention. 
Part II, Aim 2.  To finalize daytime intervention components for a comprehensive 
sleep-wake intervention for frail older adults and explore feasibility and acceptability 
using a pilot trial. Approach: An enhanced intervention addressing both nighttime and daytime 
activities will be developed based on prior evidence and further informed by data gathered in 
Part I. A successive cohort design will be utilized to evaluate and refine key intervention 
components and gather feedback on older adults’ experiences.  

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Methods and Measures 
Design 
This two-part study includes an observational sequential mixed methods design (Part I followed 
by a non-randomized pilot trial of a brief sleep-activity intervention - Part II). All participants 
enrolled in the pilot trial will receive the intervention, all activities will be unblinded. Note that 
participants will be recruited from the Principal Investigator’s ongoing work distributing a patient-
facing survey, How Are You Sleeping?. Note that this survey has received separate IRB 
approval (AMAZE Sleep Cohort: IRB00090470). In brief, all survey respondents who meet 
clinical criteria for chronic insomnia and who do not opt out of future contact are entered into the 
recruitment pool for multiple studies. 
Part I, Aim 1. Older adults obtaining primary care via Atrium Health Wake Forest Baptist 
(AHWFB) will participate in a comprehensive sleep health assessment. This two-part, in-person 
visit will consist of validated sleep-health assessments, objective sleep-activity monitoring (via 
sleep watch (e.g., Fitbit) and daily diary), and a subset of physical performance measures. At 
the conclusion of the second visit, older adults will be asked to respond to a brief set of open-
ended questions on treatment preferences. We plan to enroll up 40 older adults in this aim. 
Eligibility criteria is described below. 
Part II, Aim 2. A one-arm, non-randomized pilot study will be conducted using a successive 
cohort design. Each cohort will include four to six participants. All participants will receive the 
intervention in a group setting. After each cohort, the study team will review intervention session 
notes and other study materials to determine whether what, if any, refinements should be made 
to the intervention content or study procedures. Participants will be older adults who are 
currently receiving primary care at AHWFB, meet criteria for poor sleep and low activity, and live 
within the greater Winston-Salem region. Specific inclusion and exclusion criteria are described 
below.  
The intervention includes a four-session, in-person program delivered by a Master’s-level 
provider. All participants will complete a sleep-health assessment before the intervention 
identical to Part I, Aim 1 (NOTE: If a participant was enrolled and completed Aim1 assessments, 
only select assessments will be collected during the pre-intervention assessment, including the 
Insomnia Severity Index, sleep watch, and a sleep-activity diary. These materials may be sent 
to the participant via postal mail prior to session 1.) Prior to enrollment, study staff will review 
each participant’s sleep-health assessment, daily diary and actigraph (if applicable). This review 
will help to evaluate a participant’s “fit” for the intervention (i.e., no unaddressed health concerns 
that may negatively limit participation in the group-based intervention).  
Each session will be approximately 30-45 minutes in length, and include education and 
coaching on developing healthy nighttime sleep and daytime activity behaviors. Participants will 
complete daily sleep-activity diaries throughout the course of the intervention, and study staff 
will review these weekly with each participant either via phone call or in person within 24 hours 
of each following session. At the end of each session, the Interventionist will complete a detailed 
Session Note that will track material covered, personalized recommendations, and any 
questions asked. All participants will complete a sleep-health assessment after the intervention 
(including select assessments: SF-12, Geriatric Pain Measure, PHQ-9, Pittsburgh Sleep Quality 
Index, Insomnia Severity Index, Epworth Sleepiness Scale, Flinders Fatigue Scale). Participants 
will also be asked to provide feedback on their experience receiving SWELL.  

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Setting 
Older adults utilizing outpatient primary care clinics belonging to AHWFB. All activities will take 
place within a clinical setting. Participants will be asked to monitor their sleep-activity behaviors 
while at home. 
Subjects selection criteria 
This study will focus on older adults with clinically significant insomnia disorder (per DSM-V and 
International Classification of Sleep Disorders [ICSD] Diagnostic Criteria), as identified by a 
patient-reported survey (described elsewhere). Additional eligibility criteria are described below. 
Inclusion Criteria 
Older adults 
Older adults who return a completed survey, do not opt out of further contact, and who meet 
clinical diagnostic criteria for insomnia will be invited to participate in an in-person assessment. 
Eligibility criteria for all study phases will include the following:  
1. Age 65 or over;
2. One or more outpatient primary care visits to Wake Forest Baptist Health in the
prior 12 months;
3. Meets DSM-5 diagnostic criteria for Insomnia Disorder;
4. Less than 30 minutes of daily activity or less than 150 minutes total weekly
activity for one month or longer, as reported on brief telephone screener;
5. Able to ambulate safely (with or without an assistive device);
6. Able to follow study directions;
7. Able to communicate and follow study instructions;
8. English speaking.
Exclusion Criteria 
Exclusion criteria for patient participants include one or more of the following: 
1. Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg
syndrome);
2. Serious or unstable medical or psychiatric condition that would prevent participation in a
behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder,
substance abuse disorder);
3. Lack of decision-making capacity, as documented in medical record;
4. Referred to institutional care and/or currently residing in a nursing home or other
residential facility.
Sample Size 
Up to 40 older adults meeting DSM-V diagnostic criteria for insomnia will be invited to complete 
an in-person sleep health assessment (Aim 1).  
Up to 12 older adults will be recruited to participate in the pilot trial (Aim 2). 
Interventions and Interactions 

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This two-phased study consists of an observational aim (descriptive data collection only) (Part I) 
followed by an intervention-based aim (Part II). Interactions and interventions of the three study 
aims are described below. Note: prior to beginning Aim 1 or Aim 2, all patient participants will 
complete a telephone eligibility screener that will include brief questions on sleep and activity. 
 
Observational Aims (Interaction Only): 
Part I, Aim 1: (Sleep Health Assessment):  Older survey respondents who meet clinical criteria 
for insomnia will be invited to participate in an two-part in-person sleep and health assessment. 
Data collection activities are described in the table below. 
 
Overview of In-Person Sleep Health Assessment 
 
Visit 1: Health Assessment 
Visit 2: Sleep and Activity Assessment 
Health and demographic assessments 
Demographics questionnaire 
Health: SF-121, Charlson Comorbidity Index2, Geriatric 
Pain Measure4 , PHQ-95 
Function: Self-reported measures: ADLs/IADLs6 
Sleep measures 
Pittsburgh Sleep Quality Index,38 Insomnia Severity 
Index,39 STOP Questionnaire for Sleep Apnea,40 
Epworth Sleepiness Scale41, Flinders Fatigue Scale3 
 
Open-ended items 
• Definitions and perceptions of functional independence 
• How are nighttime sleep and daytime activity 
behaviors related? 
• How do sleep and activity behaviors impact overall 
function? 
• What other outcomes matter to you? 
Open-ended items 
• Preferences for health promotion programs: mode of 
delivery, type of provider, dose, support between 
sessions 
• Social and physical environment (barriers and 
facilitators to daily movement and activity) 
Sleep watch and daily diary 
Three to five days of continuous daytime and nighttime 
sleep watch monitoring36 plus daily sleep-activity diary37 
(Wake-up prompts: sleep-wake schedule, nighttime 
awakenings, overall sleep quality. Morning, Midday, 
Afternoon/Evening, & Bedtime prompts: daytime activity, 
sedentary time, mood, pain, fatigue levels) 
Functional assessment 
Functional performance tests: Short Performance 
Physical Battery (SPPB)7 
 
 
 
Intervention Aim (Treatment): 
 
Part II, Aim 2 (Sleep Health Education Program). A one-arm, non-randomized pilot study will be 
conducted using a successive cohort design. Each cohort will include four to six participants . 
Participants will be older adults who are currently receiving primary care at AHWFB, meet 
criteria for poor sleep and low activity, and live within the greater Winston-Salem region. 
Specific inclusion and exclusion criteria are described below. All participants will receive the 
intervention in a small-group setting. Group sessions will be conducted in-person or virtually. 
Participants will complete pre- and post-program assessments in addition to daily sleep-activity 
diaries throughout the course of the intervention. Note: all assessments will be identical to those 
used in Aim 1 – if a participant has completed Aim 1, an abbreviated assessment will be 
administered to include the Insomnia Severity Index and a daily sleep diary. The intervention 
includes a four-session program delivered by a Master’s-level provider. Each session will be 
approximately 30-45 minutes in length. Each session will include education and coaching on 
developing healthy nighttime sleep and daytime activity behaviors. At the end of each session, 
the Interventionist will complete a detailed Session Note that will track material covered, 
personalized recommendations, and any questions asked. All participants will complete a post-
intervention assessment (including select assessments: SF-12, Geriatric Pain Measure, PHQ-9, 
Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, Flinders 
Fatigue Scale). Participants will also be asked to provide feedback on their experience receiving 

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SWELL. After each cohort, the study team will review intervention session notes and study 
assessments to determine whether what, if any, refinements should be made to the intervention 
content or study procedures. 
 
The behavioral intervention is based on the Principal Investigator’s prior work developing and 
testing an evidence-based behavioral sleep intervention for older adults.8 In short, the prior 
intervention focused solely on improving nighttime sleep problems. An overview of the proposed 
content is provided below. Final content, including daytime activity components of the 
intervention, will be refined during the course of the study (based on Aims 1 and 2 findings and 
feedback). Sample content is included as an attachment to this application. 
 
 
 
Visit 
Timing 
Activities 
Data Collection 
Time 
Required 
Baseline 
 
Week 0 
(Visit 1)  
 
Week 1 
(Visit 2) 
Pre-Intervention Assessment 
Quantitative assessments, sleep 
watch, and sleep-activity diary 
Note: Assessments identical to 
those described in Aim 1.* 
 
*If participant completed Aim 1, 
Visit 1 and 2 will be collapsed and 
only select questionnaires will be 
administered (see abbreviated 
pre-program assessment 
attached). 
60 minutes 
Session 1 
Week 2 
SWELL24 Session 1 
Sleep and activity: 
Understanding a 24 hour cycle 
Sleep-activity diary 
30 minutes 
Session 2 
Week 3 
SWELL24 Session 2 
Following a regular sleep-wake 
schedule, including tips for 
daytime engagement 
Sleep-activity diary 
30 minutes 
Session 3 
Week 4 
SWELL24 Session 3 
Optimizing daytime routines and 
activities 
Sleep-activity diary 
30 minutes 
Session 4 
Week 5 
SWELL24 Session 4 
Relapse prevention and long-
term strategies 
Sleep-activity diary 
 
Give sleep watch and sleep diary 
to return at post-intervention 
assessment. 
30 minutes 
Post-
Treatment 
Week 6 
 
 
Post-Intervention Assessment 
Quantitative assessments, review 
sleep watch and sleep-activity 
diary. Note: Select assessments 
administered in Aim 2: SF-12, 
Geriatric Pain Measure, PHQ-9, 
Pittsburgh Sleep Quality Index, 
Insomnia Severity Index, Epworth 
Sleepiness Scale, Flinders Fatigue 
Scale. 
 
At the end of the visit, participants 
will also be asked to provide 
feedback on their experience 
receiving SWELL24. 
60 minutes 
 
 
Outcome Measure(s) 
 

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Primary outcome: sleep efficiency (per sleep watch) 
Secondary outcome: total daytime activity (per sleep watch); insomnia severity (per self-
reported Insomnia Severity Index); daytime consequences (per self-reported assessment, daily 
diary) 
 
Analytical Plan 
Aim 1: Sleep-Health Assessment 
Descriptive statistics will be calculated for all validated assessments. Multivariate statistics will 
be used to identify predictors (i.e., clinical and demographic characteristics collected in 
quantitative assessments) of objective poor sleep and poor activity. To estimate the relationship 
between co-occurring poor sleep-activity behaviors and physical function, Pearson and 
Spearman correlations, along with their 95% confidence intervals, will be calculated for 
continuous measures of objective sleep and activity. To explore the relationship between poor 
sleep-wake behaviors on physical function, a series of regression models will be run to observe: 
(a) the relationship of poor objective sleep on physical function, (b) the relationship of poor 
objective activity on physical function, (c) the relationship of co-occurring poor sleep-poor 
activity on physical function, and whether in combination, the two behaviors predict physical 
function better than either one individually. We aim to enroll up to 40 older adults in this aim.  
 
 
Aim 2: Pilot Feasibility Trial 
The objective of the pilot feasibility trial is to gather preliminary information to inform a fully-
powered randomized trial. To this end, the pilot trial is not powered to detect a statistically 
significant difference in treatment outcomes rather we are interested in detecting any signal 
indicating a treatment effect. In preparation for a larger trial, we will collect the following: 
Retention rate. This will be defined as the number of participants who completed all intervention 
sessions out of the total number enrolled. Adherence to personalized recommendations. 
Adherence to personalized behavioral recommendations is a key measure of acceptability. This 
information will be gathered through process notes recorded after each intervention session and 
in sleep and activity diaries completed on a daily basis. Response to intervention: In order to 
determine dose, sequencing and timing of intervention components to be used in a larger trial, 
participants will report daily sleep-wake behaviors using daily diary. In preparation for a full trial, 
we will evaluate whether selected functional measures are sensitive to change over the study 
period. Primary outcomes will include objective daytime activity and nighttime sleep efficiency, 
both will be obtained from the sleep watch. Intervention acceptability. Following the completion 
of the intervention, and at the end of the post-intervention assessment, semi-structured 
interview questions will be used to assess acceptability of the intervention and assessment 
visits.  
 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Subjects will primarily be recruited via a patient-facing postal survey, How Are You Sleeping? 
Details of this survey are described in the following protocol: IRB00090479. 
 
In brief, completed surveys in which subjects have not opted out of further contact will be 
eligible for recruitment into subsequent study aims. In order to ensure equal access to 
participation among all subject groups, our team will utilize a block approach to recruitment. In 
short, we will review 25 completed surveys at a time. Within each block, we will review 

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demographic characteristics to ensure women and minority participants are represented. We 
will oversample these groups, as needed. 
 
All study recruitment will take place via personal telephone calls to research subjects. In each 
phase of the study, research staff will call eligible subjects, describe the purpose of the study 
and its goal, review expectations for participation, and answer any questions the subject might 
have. Each patient recruitment call will begin with a brief telephone screener to collect more 
detailed information on the patient’s sleep and activity behaviors.  
 
Note: Any participants who have completed Aim 1 sleep health assessments may be eligible for 
enrollment in the pilot trial (Aim 2). If a subject who has completed Aim 1 indicates interest in 
participating in the pilot trial, their assessment data will be reviewed prior to recruitment and 
enrollment into the pilot trial. 
 
All protected health information used for recruitment purposes (e.g., name, gender, age, 
address, telephone number) will be stored in password-protected folders on designated server 
space. Study staff will indicate participants who do not agree to participate. All information will 
remain on file for the course of the study. Any information for individuals who did not agree to 
participate will be destroyed at the time of study completion.  
 
 
 
 
Informed Consent 
 
As described throughout this protocol, participants will be recruited from the Principal 
Investigator’s ongoing work distributing a patient-facing survey, How Are You Sleeping? 
(IRB00090479).  
 
All study activities for the proposed work, including in-person assessments (Aim 1) and pilot trial 
participation (Aim 2), will follow a series of progressive steps to obtain signed informed consent.  
• 
Step 1 – Telephone Screener: Research staff will call eligible participants (defined as 
older adults who respond to How Are You Sleeping? survey, meet diagnostic criteria for 
insomnia, and do not opt out of future contact) to present the study, including its purpose 
and requirements for participation. If a subject indicates interest in participating, verbal 
consent will be obtained to proceed with a brief telephone screener. In short, this 
telephone screener will assess the following: age, type and location of residence, 
functional independence, no unaddressed medical concerns and/or upcoming 
treatments that would interfere with participation. 
• 
Step 2* – Scheduling an In-Person Study Visit: For participants who are deemed eligible 
per the brief telephone screener, research staff will schedule an in-person visit, and 
explain the expectations of the visit, including the process of obtaining written informed 
consent. We will offer to mail a blank copy of the consent document if the subject wishes 
to review prior to the visit. 
• 
Step 3* – Consent Presentation and Signature: At the start of the visit, research staff will 
use a brief slideshow to review all elements of the consent document. The research staff 
will then provide time for the subject to ask any questions about the study, its 
expectations, or elements of the consent document. To demonstrate understanding of 
the study and consent document, the research staff will ask the subject to respond to 
four brief questions (purpose of study, required activities, anticipated risks, and how to 
stop participation). Participants must provide a correct response to all questions to 

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proceed. Once the participant has correctly responded to all items on the consent 
capacity screener, they will be asked to sign the consent document. 
 
*For participants enrolling in the pilot trial (Aim 2) who have also completed Aim 1:  
- 
The consent visit for Aim 2 may be completed virtually via REDCap through an online 
survey platform which can be accessed on a computer, mobile phone, or tablet. A virtual 
visit will be scheduled with a research staff member using a secure platform (e.g., 
Webex). The participant will be able to open the survey link during the visit, read and 
review the document with the research staff. When they get to the bottom of the 
document, they will be able to sign their name if they agree to participate. The REDCap 
eConsent Framework adds an extra certification page to the end of the survey with a 
read-only PDF copy of the informed consent document; they will be asked to confirm 
that all of the information in the document is correct and that by signing the form 
electronically, it is the equivalent of signing a physical document. The participant will 
receive a PDF copy of the signed informed consent. The survey responses will be stored 
in a REDCap project that is separate from any de-identified participant data. If the 
consent visit is completed virtually, then the pre-program assessment (Insomnia Severity 
Index) may be shared with the participant via an electronic REDCap survey during after 
consent has been obtained.  
 
 
 
Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner.  To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the data 
collection form.  Any collected patient identifying information corresponding to the unique study 
identifier will be maintained on a linkage file, store separately from the data.  The linkage file will 
be kept secure, with access limited to designated study personnel.  Following data collection 
subject identifying information will be destroyed six years after the closure of the study. All 
identifying information will be physically destroyed. All remaining research records will be de-
identified, consistent with data validation and study design, producing an anonymous analytical 
data set.  Data access will be limited to study staff.  Data and records will be kept locked and 
secured, with any electronic data password protected.  No reference to any individual participant 
will appear in reports, presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 
 
The principal investigator will be responsible for the overall monitoring of the data and 
safety of study participants.  The principal investigator will be assisted by other members of the 
study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
 
Any unanticipated problems, serious and unexpected adverse events, deviations or 
protocol changes will be promptly reported by the principal investigator or designated member 
of the research team to the IRB and sponsor or appropriate government agency if appropriate. 
 
 
 

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Appendix 
1. Telephone recruitment script 
2. Informed consent document (older adults) 
3. Sleep-health assessments (patient) [Aim 1, Aim 2] 
4. Sleep-activity diary 
5. Sample intervention materials 
 
 
 

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1. 
Ware JE, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: Construction of 
Scales and Preliminary Tests of Reliability and Validity. Medical Care. 1996;34(3):220-
233. 
2. 
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying 
prognostic comorbidity in longitudinal studies: Development and validation. Journal of 
Chronic Disease. 1987;40(5):373-383. 
3. 
Gradisar M, Lack L, Richards H, et al. The Flinders Fatigue Scale: Preliminary 
Psychometric Properties and Clinical Sensitivity of a New Scale for Measuring Daytime 
Fatigue associated with Insomnia. Journal of Clinical Sleep medicine. 2007;3(7):722-
728. 
4. 
Ferrell BA, Stein WM, Beck JC. The Geriatric Pain Measure: Validity, Reliability, and 
Factor Analysis. Journal of the American Geriatrics Society. 2000;48:1669-1673. 
5. 
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity 
measure. J Gen Intern Med. 2001;16(9):606-613. 
6. 
Duke University Center for the Study of Aging and Human Development. Duke Older 
Americans Resources and Services Program: An Information System for Functional 
Assessment. Center Reports on Advances in Research. 1985;9. 
7. 
Guralnik JM, Simonsick EM, Ferrucci L, et al. A short physical performance battery 
assessing lower extremity function: Association with self-reported disability and 
prediction of mortality and nursing home admission. Journal of Gerontology: Medical 
Sciences. 1994;49(2):M85-M94. 
8. 
Martin JL, Song Y, Hughes JM, et al. A four-session sleep intervention program 
improves sleep for older adult day health care participants: Results of a randomized 
controlled trial. Sleep. 2017;40(8):097.