Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns

Официальное название

A Pilot Feasibility Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns

Обзор

This is an eight-week pilot research study designed to test whether simple changes to the bedroom environment along with brief sleep hygiene strategies, can improve sleep in older adults who live alone, have memory concerns, and experience insomnia symptoms. Older adults may be eligible to participate. The intervention will take 8 weeks, which includes 1-2 in-person visits from the research team at the participant's residence (evaluate the bedroom environment, install participant-agreed bedroom changes, deliver target sleep hygiene strategy) and 2 virtual or telephone calls (support environmental and sleep hygiene strategies) over 8 weeks. Sleep and environment data will be collected at screening/baseline, mid-intervention (4-week) and post-intervention (8-week)

Вмешательства

• Поведенческое Bedroom Environment Tailoring
  Within two weeks of completing the parent study and consent, participants begin the personalized bedroom sleep environment program. During in one or two in-home visits, a research team member will review baseline sensor and actigraphy data and install low-cost environmental modifications (e.g., blackout shades, white-noise device, air purifier, thermostat adjustments). Participants collaborate with the coach to set stimulus-control goals and receive individualized sleep-hygiene guidance. A 30-45
• Поведенческое Sleep Health Education
  The control group receives a single in-person or virtual session that provides participants with printed and online sleep health education materials. This introductory session aims to equip participants with foundational knowledge about sleep hygiene. Following this initial session, participants will engage in eight weeks of self-directed practice, allowing the participant to apply the information learned at the participant's own pace.

Первичные конечные точки

• Feasibility of study and intervention [Срок оценки: Duration of study, approximately 2 years]
• Subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, 4-weeks, 8-weeks]

Критерии участия

Критерии включения

• Age 65 years and older
• Living alone in a private residence or independent living setting ≥5 days/week
• Subjective cognitive decline (Subjective Cognitive Decline Questionnaire MyCog > 7\] OR objective mild cognitive impairment (Montreal Cognitive Assessment \[MoCA\] scores between 18-25).
• Preserved Function (Functional Activity Questionnaire < 6)
• Community-dwelling
• Self-reported insomnia symptoms
• Residence in the current home for ≥3 months
• Expectation to sleep in the designated bedroom on ≥80% of nights during the 8 week protocol

Критерии исключения

• Diagnosis of dementia
• Presence of acute illness or exacerbation of chronic conditions within the past month.
• Current enrollment in another intervention study

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07440498 · IRB00543636

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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