A Pilot Feasibility Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Feasibility of study and intervention
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of dementia
- •Presence of acute illness or exacerbation of chronic conditions within the past month.
- •Current enrollment in another intervention study
研究组 & 干预措施
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 participants to apply the information learned at the participant's own pace.
干预措施: Sleep Health Education (Behavioral)
Bedroom Environment Tailoring
干预措施: Bedroom Environment Tailoring (Behavioral)
结局指标
主要结局
Feasibility of study and intervention
时间窗: Duration of study, approximately 2 years
Feasibility will be assessed by recruitment, retention, fidelity, and safety over the study period, with progression thresholds: ≥70% eligible enrollee ≥85% retained to Week 8, treatment fidelity (coaching delivered ≥80%), and no serious intervention-related adverse events.
Subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, 4-weeks, 8-weeks
Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure of overall sleep quality and disturbances over the past 30 days. It includes seven component scores-subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction-each scored 0-3 (0 = no difficulty; 3 = severe difficulty). Component scores are summed to a global score (0-21), with higher scores indicating worse sleep quality; the global score will be used in the analysis
次要结局
未报告次要终点