Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners (NCT06250725) | Clinical Trial Compass
RecruitingNot Applicable
Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
United States80 participantsStarted 2024-08-01
Plain-language summary
The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.
Who can participate
Age range
18 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 for the PLwCI:
* Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment or
* Montreal Cognitive Assessment (MOCA) score between 12 and 24;
* Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale;
* Have an eligible caregiver;
* Be able to participate in the intervention sessions
Inclusion Criteria for Caregivers:
* ≥18 years old, co-residing with persons living with cognitive impairment (PLwCI);
* Regularly assist the care recipient with ≥1 of 7 basic activities of daily living or
* ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months;
* Have difficulty falling asleep or difficulty staying asleep for the last three months or
* Have a Pittsburgh Sleep Quality Index (PSQI) of 5 or greater
Exclusion Criteria:
* PLwCI: Moderate to severe cognitive impairment
* Individuals who are not yet adults
* Pregnant women
* Prisoners
* Individuals who are not able to clearly understand English.
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
Change in insomnia
Timeframe: Baseline, 1-week post-intervention, and 3 months post-intervention
2
Change in Sleep Efficiency
Timeframe: Baseline, 1-week post-intervention, and 3 months post-intervention
3
Change in in Sleep Onset Latency
Timeframe: Baseline, 1-week post-intervention, and 3 months post-intervention
4
Change in Wake After Sleep Onset
Timeframe: Baseline, 1-week post-intervention, and 3 months post-intervention
5
Adherence with Study Interventions (feasibility)
Timeframe: weekly during the intervention period up to 3 months post-intervention