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NCT Number: NCT07572565

REPAIR Sleep Study

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

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Key information

Conditions

Cognition Disorder Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Sleep disturbance is highly prevalent among persons living with Alzheimer's disease and related dementias (PLwD) and their caregivers. PLwD commonly experience fragmented sleep, increased wake after sleep onset, and frequent nighttime awakenings, which often require caregiver supervision. As a result, caregivers often experience poor sleep quality, shorter sleep duration, and symptoms of insomnia. Sleep disturbance in both members of the dyad is associated with poorer psychological health, reduced quality of life, and earlier residential placement of PLwD.

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line, evidence-based treatment for insomnia and has demonstrated effectiveness across diverse populations, including when delivered via videoconferencing. CBT-I targets behavioral and cognitive factors that perpetuate insomnia, using strategies such as stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. Prior research suggests that caregiver involvement can enhance the implementation of behavioral sleep strategies for PLwD and may improve outcomes for both members of the dyad.

This study will test REPAIR Sleep, a 5-week CBT-I intervention delivered virtually to caregiver-PLwD dyads. The intervention incorporates behavioral sleep strategies, cognitive techniques, and collaborative problem-solving. Written and recorded agreements and daily logs are used to support memory challenges in PLwD and promote consistent practice of sleep-related behaviors. Dyads randomized to the comparison group will receive Healthy Living, an attention-matched program focused on general wellness topics unrelated to sleep.

The study will evaluate immediate and 6-month changes in insomnia severity, sleep efficiency, sleep onset latency, and wake after sleep onset, measured through validated questionnaires, sleep diaries, and actigraphy. Psychological outcomes-including affect, depressive symptoms, stress, and quality of life-will also be assessed. The study will further examine whether adherence to REPAIR Sleep components and interpersonal support within the dyad are associated with improvements in sleep and psychological outcomes. Participants will be followed for approximately 9 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

PLwCC and Caregiver

  • 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)
  • Community-dwelling
  • Co-residing with each other
  • Have internet access
  • No history of surgery in the past 4 weeks

Caregivers -Regularly assist the care recipient with ≥1 of 7 basic activities of daily living61 or ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months.

PLwD

-Reported or diagnosed cognitive impairment; able to complete simple directives.

Exclusion criteria

PLwCC or Caregiver:

  • 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
  • Plan trans-meridian travel during the period of data collection blocks
  • Hearing or visual impairment

Caregivers

  • Dementia or cognitive impairment.
  • Individuals who are not yet adults
  • Pregnant women
  • Prisoners
  • Individuals who are not able to clearly understand English.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Change in total sleep time (TST)

    Time frame: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

    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.

  2. Change in sleep efficiency (SE)

    Time frame: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

    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.

  3. Nocturnal awakenings

    Time frame: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

    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.

  4. Change in Quality of life

    Time frame: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

    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.

  5. Depressive symptoms

    Time frame: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

    Change in depressive symptoms measured using the Center for Epidemiologic Studies Depression Scale (CES-D).

    • Items: 20 self-report items
    • Scale: each item rated 0-3 based on frequency of symptoms
    • Score Range: 0-60
    • Direction: higher scores indicate more severe depressive symptoms; scores ≥16 often indicate clinically relevant depressive symptoms in research contexts Data will be reported as total CES-D score and change from baseline for caregivers and PLwD.

  6. Positive and Negative Affect

    Time frame: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

    Change in affect measured using the Positive and Negative Affect Schedule (PANAS). The PANAS includes two 10-item subscales:

    • Positive Affect (PA): measures enthusiasm, alertness, and activity
    • Negative Affect (NA): measures distress and unpleasurable engagement

    Each item is rated on a Likert scale (e.g., 1-5), and subscale scores are summed:

    • Score Range: typically 10-50 for each subscale
    • Direction: higher PA = more positive affect; higher NA = more negative affect Data will be reported as PA and NA subscale scores and change from baseline for each dyad member.

  7. Percieved stress

    Time frame: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

    Change in perceived stress measured using the Perceived Stress Scale (PSS). The PSS is a widely used self-report questionnaire assessing the degree to which situations in one's life are appraised as stressful over the past month.

    • Scale: typically 10 items (PSS-10), each rated 0-4
    • Score Range: 0-40
    • Direction: higher scores indicate greater perceived stress Data will be reported as total PSS score at each time point and change from baseline for caregivers and PLwD separately.

Study contacts

Contact information is provided by the study sponsor or research team.

Glenna S Brewster, PhD, RN

CONTACT

[email protected]

(404) 712-9164

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Testing Cognitive Behavioral Therapy for Insomnia (CBT-I) on Dyadic Sleep in Dementia: A Randomized Control Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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