Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory… (NCT07440498) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns
40 participantsStarted 2026-10
Plain-language summary
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)
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Diagnosis of dementia
* Presence of acute illness or exacerbation of chronic conditions within the past month.
* Current enrollment in another intervention study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of study and intervention
Timeframe: Duration of study, approximately 2 years
2
Subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)