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REPAIR Sleep Study

1. mai 2026 oppdatert av: Glenna Brewster, Emory University

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

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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)

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.

Aktiv komparator: 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

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in insomnia severity
Tidsramme: 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.
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in total sleep time (TST)
Tidsramme: 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.

Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32
Change in sleep efficiency (SE)
Tidsramme: 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.

Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32
Nocturnal awakenings
Tidsramme: 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.
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
Tidsramme: 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.
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32
Depressive symptoms
Tidsramme: 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.
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32
Positive and Negative Affect
Tidsramme: 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.
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32
Percieved stress
Tidsramme: 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.
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Glenna Brewster, PhD, RN, Emory University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

1. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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