REPAIR Sleep Study

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое REPAIR Sleep
  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
• Поведенческое Healthy Living
  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 s

Первичные конечные точки

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

Вторичные конечные точки (7)

• Change in total sleep time (TST) [Срок оценки: 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) [Срок оценки: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32]
• Nocturnal awakenings [Срок оценки: 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 [Срок оценки: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32]
• Depressive symptoms [Срок оценки: 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 [Срок оценки: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32]
• Percieved stress [Срок оценки: Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07572565 · 2025P013860 · 1R01AG093890-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗