REPAIR Sleep Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
The goal of this study is to learn whether a videoconference-delivered CBT-I program (REPAIR Sleep) can improve sleep and psychological well-being in caregiver-PLwD dyads. The main questions it aims to answer are:
* Does REPAIR Sleep improve insomnia severity and other sleep outcomes? * Does REPAIR Sleep improve psychological outcomes such as mood, stress, and quality of life? Researchers will compare REPAIR Sleep with Healthy Living to see whether REPAIR Sleep leads to greater improvements.
Participants will:
* Attend five weekly virtual sessions * Complete sleep diaries and questionnaires * Wear an actigraphy device * Complete follow-up assessments over 9 months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have Insomnia Severity Index (ISI) ≥10
Have difficulty initiating or maintaining sleep or waking up too early at least three nights per week
Have sleep disturbances persisting for at least three months
Have daytime impairment (e.g., fatigue, mood disturbance)
Disqualifiers
A diagnosis of psychosis, major depressive disorder, or bipolar disorder that is not currently treated;
Having had substance or alcohol dependency, or active suicidality in the past year
Currently have narcolepsy or restless leg syndrome
Does shift work
Trial design
Design model
Parallel
Treatments tested in this trial
REPAIR Sleep
BehavioralREPAIR Sleep is a dyadic CBT-I program delivered via videoconferencing over 5 weekly sessions (60 minutes each). Core components include: * Stimulus control: establishing consistent wake times and strengthening the bed-sleep association * Sleep compression: gradually adjusting time in bed to improve sleep efficiency, using a milder form appropriate for older adults and PLwD * Relaxation training: techniques to reduce physiological and cognitive arousal at bedtime; can be practiced individually or together * Cognitive therapy: identifying and modifying unhelpful thoughts and beliefs about sleep and its consequences * Sleep hygiene education: optimizing environmental and behavioral factors that influence sleep The intervention uses written and recorded agreements and daily logs to support memory challenges in PLwD and to promote consistent practice of sleep behaviors. Both dyad members attend all sessions.
Healthy Living
BehavioralHealthy Living is an attention-matched, 5-week behavioral health education program delivered via videoconferencing. Weekly 60-minute sessions cover: * Week 1: Healthy aging principles, components of a healthy lifestyle, nutrition basics, budgeting for nutritious meals, meal planning, and food journaling * Week 2: Sleep hygiene education, introduction to flexibility exercises and stretches, activity journaling, and goal setting * Week 3: Balance exercises, fall prevention strategies (including safe bed exits at night), and weight-bearing aerobic exercise * Week 4: Strength training using resistance bands and light weights * Week 5: Integration of exercise, nutrition, and sleep hygiene; review and goal setting for continued healthy living The program emphasizes goal setting, progress tracking, and behavioral reinforcement, with dyads encouraged to implement lifestyle changes and discuss successes and challenges during sessions.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: REPAIR SleepExperimental treatment 1 intervention
Group B: Healthy LivingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in insomnia severity
Change in insomnia symptom severity, measured using the Insomnia Severity Index (ISI), a 7-item validated self-report scale assessing difficulty falling asleep, staying asleep, early awakenings, satisfaction with sleep, interference with daily functioning, noticeability of impairment, and distress caused by sleep problems. Scores range from 0-28, with higher scores indicating more severe insomnia symptoms.
Time frame
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32Secondary outcomes
1
Change in total sleep time (TST)
This will be reported as a change in total minutes scored as sleep per night. Data will be collected through actigraphy. Actigraphy provides continuous movement-based estimates of sleep-wake patterns. Higher TST indicates better sleep.
Time frame
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 322
Change in sleep efficiency (SE)
This will be reported as a percentage of time in bed spent asleep Data will be collected through actigraphy. Actigraphy provides continuous movement-based estimates of sleep-wake patterns. Higher (SE) indicates better sleep.
Time frame
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 323
Nocturnal awakenings
This will be reported as the count of awakenings per night. Data will be collected through actigraphy. Actigraphy provides continuous movement-based estimates of sleep-wake patterns.
Time frame
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 324
Change in Quality of life
Change in quality of life measured using the World Health Organization Quality of Life - BREF (WHOQOL-BREF). This instrument assesses four domains: * Physical Health * Psychological * Social Relationships * Environment Items are rated on a Likert scale and transformed to domain scores: * Score Range: domain scores typically scaled 0-100 * Direction: higher scores indicate better quality of life Data will be reported as domain scores and, if desired, an overall summary, with change from baseline for each dyad member.
Time frame
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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