Couples Health Aging, Rhythms and Sleep Study (NCT05952284) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Couples Health Aging, Rhythms and Sleep Study
United States340 participantsStarted 2023-09-14
Plain-language summary
Alzheimer's disease and related dementias (ADRD), including mild cognitive impairment (MCI), are becoming among the most prevalent causes of disability, death and healthcare costs worldwide. Sleep and circadian rhythm disturbances are common among individuals with MCI as well as their spouses/ partners and may increase risk of the development of ADRD in both patients and partners. This is the first study to systematically investigate sleep as a shared health behavior within couples in which one member has MCI, and the degree to which sleep and circadian disturbances impact both partners health and well-being, including cognitive decline and risk for ADRD.
Who can participate
Age range
50 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:
* Married or partnered in a romantic relationship, cohabiting for at least two years
* age \>50
* smartphone user
* one partner meets criteria for cognitive impairment without severe impairment in daytime dysfunction according to telephone screening, while other partner must not meet this criteria for impairment.
Exclusion Criteria:
* Unstable or severe medical or psychiatric conditions that would interfere with study participation (including but not limited to current cancer treatment, psychosis, history of major stroke, head injury with loss of consciousness \>30 min, other neurologic/systemic illness that may affect cognition, alcohol or other substance abuse)
* current use of antipsychotic or anticonvulsant medications
* inadequate vision, hearing, or dexterity to participate in the assessment
* night shift work \>1x per month (defined as beginning work after 9:00 pm or work in the overnight hours \[12:00 am-5:00 am\])
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
Digit symbol: daily score
Timeframe: This study will evaluate day to day change in digit symbol performance over 10 days.
2
Memory: daily score
Timeframe: This study will evaluate day to day change in digit symbol performance over 10 days.