- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07572565
REPAIR Sleep Study
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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Glenna S Brewster, PhD, RN
- Telefonní číslo: (404) 712-9164
- E-mail: glenna.brewster@emory.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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:
|
REPAIR Sleep is a dyadic CBT-I program delivered via videoconferencing over 5 weekly sessions (60 minutes each). Core components include:
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. |
|
Aktivní komparátor: 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:
|
Healthy Living is an attention-matched, 5-week behavioral health education program delivered via videoconferencing. Weekly 60-minute sessions cover:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in insomnia severity
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in total sleep time (TST)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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:
Items are rated on a Likert scale and transformed to domain scores:
|
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32
|
|
Depressive symptoms
Časové okno: 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).
|
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
Časové okno: 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:
Each item is rated on a Likert scale (e.g., 1-5), and subscale scores are summed:
|
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32
|
|
Percieved stress
Časové okno: 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.
|
Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Glenna Brewster, PhD, RN, Emory University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025P013860
- 1R01AG093890-01A1 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na REPAIR Sleep
-
Massachusetts General HospitalStaženoHypertrofické jizvySpojené státy
-
Pomeranian Medical University SzczecinDokončenoZubní kaz, Zubní
-
Quanta MedicalNAOS Institute of Life ScienceDokončenoSyndrom ruka-noha 2. stupněFrancie
-
Barts & The London NHS TrustKing's College Hospital NHS Trust; Royal Brompton & Harefield NHS Foundation... a další spolupracovníciZatím nenabíráme
-
University of PaviaDokončenoZubní kaz | Zubní výplněItálie
-
MedtronicNeuroUkončenoGastroezofageální refluxní chorobaSpojené státy, Holandsko
-
Ain Shams Maternity HospitalDokončeno
-
Goldman, Butterwick, Fitzpatrick and GroffBabor AmericasZatím nenabírámeStárnutí kůže | Vrásky na obličeji
-
Ankara City Hospital BilkentAnkara Etlik City HospitalNáborZranění kolena | Léze menisku | Slza menisku | Fibrinová krevní sraženinaTurecko (Türkiye)
-
Segeberger Kliniken GmbHNáborMitrální regurgitace (MR)Německo