REPAIR Sleep Study

Sponsor
Emory University
Study ID
NCT07572565
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REPAIR Sleep — BEHAVIORAL
    REPAIR 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 — BEHAVIORAL
    Healthy 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.

Study Details

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

Key Dates

First listed
May 7, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: REPAIR Sleep
    Caregiver-PLwD dyads randomized to this arm will receive REPAIR Sleep, a 5-week, 60-minute, videoconference-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention. Sessions are delivered once weekly to both members of the dyad together. The intervention targets behavioral and cognitive factors that perpetuate insomnia and is tailored to the needs of caregivers and persons living with dementia. Participants will: * Attend five weekly 60-minute virtual sessions with a trained interventionist * Review and complete sleep diaries and daily adherence checklists * Wear a wrist actigraph (CentrePoint Insight Watch) for 2 weeks before and during the 5-week intervention * Practice CBT-I components between sessions (e.g., stimulus control, sleep compression, relaxation, cognitive strategies, sleep hygiene)
  • Active Comparator: Healthy Living
    Caregiver-PLwD dyads randomized to this arm will receive Healthy Living, a 5-week, 60-minute, videoconference-delivered attention control intervention adapted from the National Institute on Aging's Go4Life program. The content focuses on general health and wellness (e.g., nutrition, physical activity, fall prevention), with sleep hygiene included as one topic. Sleep-specific behavioral and cognitive strategies from CBT-I are not provided in this arm. Participants will: * Attend five weekly 60-minute virtual sessions with a facilitator * Receive a manual and workbook with educational materials and exercises * Complete health-related journals (e.g., food intake, physical activity, sleep hygiene practices) * Wear a wrist actigraph and complete sleep diaries on the same schedule as the intervention arm

Primary Outcome Measure

Change in insomnia severity [ Time Frame: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 ]

Central Contacts

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