Stable Sleep Pattern Before Sleep Loss (NCT06201390) | Clinical Trial Compass
CompletedNot Applicable
Stable Sleep Pattern Before Sleep Loss
United States16 participantsStarted 2024-01-25
Plain-language summary
Sleep is now recognized as important for disease prevention. Too little or too much sleep contributes to cardiovascular disease. Leading health organizations recommend adults sleep 7-9 hours per night for optimal health. This recommendation is based on research that finds reductions in sleep duration elevate blood pressure and impair vasodilation of blood vessels. One question raised in a recent NIH Workshop report (PMID:36448463) is whether stable sleep patterns, irrespective of a person's sleep duration, could mitigate the adverse effects of insufficient sleep on vascular function. This project will address this question in midlife adults using a randomized, crossover designed study.
Who can participate
Age range
35 Years – 64 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:
* Women and men
* 35-64 years of age
Exclusion Criteria:
* obese based on BMI \>29 kg/m2
* night-shift work
* prior diagnosis of sleep apnea
* signs of insomnia using the Insomnia Symptom Questionnaire
* a 'poor sleeper' (global score ≥5) based on the Pittsburgh Sleep Quality Index
* taking medications that alter sleep
* personal history of stroke, coronary heart disease, diabetes mellitus
* taking antihypertensive medications
* smoker (including vaping)
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 Peak Reactive Hyperemia
Timeframe: pre-intervention; immediately after the intervention
2
Change in Arterial Stiffness
Timeframe: pre-intervention; immediately after the intervention
3
Change in Blood Pressure Reactivity
Timeframe: pre-intervention; immediately after the intervention
4
Change in Cerebral oxygenation
Timeframe: pre-intervention; immediately after the intervention