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Cognition DisorderNCT07572565

REPAIR Sleep Study

A study testing REPAIR Sleep and Healthy Living in people with Cognition Disorder and Alzheimer Disease, run by Emory University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cognition Disorder, Alzheimer Disease
What is being tested?
REPAIR Sleep and Healthy Living
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Jul 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Glenna S Brewster, PhD, RN contact

(404) 712-9164

glenna.brewster@emory.edu

About this study

Official title: Testing Cognitive Behavioral Therapy for Insomnia (CBT-I) on Dyadic Sleep in Dementia: A Randomized Control 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
Read the detailed description

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.

Being tested
REPAIR Sleep, Healthy Living
Keywords
Persons living with cognitive changes, Persons living with Alzheimer's disease and related dementias, Cognitive Behavioral Therapy for Insomnia
Medical subject headings
Cognition Disorders, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REPAIR SleepBehavioural

    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 LivingBehavioural

    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 groups in NCT07572565
Study groupRoleWhat they receive
REPAIR SleepExperimentalCaregiver-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)
Receives: Behavioral: REPAIR Sleep
Healthy LivingActive comparatorCaregiver-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
Receives: Behavioral: Healthy Living

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Depressive symptoms

    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.

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

  6. Positive and Negative Affect

    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.

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

  7. Percieved stress

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07572565
Sponsor's protocol ID
2025P013860
Other IDs
1R01AG093890-01A1
Status last verified
May 2026
First submitted
27 Apr 2026
Last updated
7 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing REPAIR Sleep and Healthy Living in people with Cognition Disorder and Alzheimer Disease, run by Emory University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Glenna S Brewster, PhD, RN ((404) 712-9164, glenna.brewster@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07572565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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