Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight an… (NCT05849181) | Clinical Trial Compass
CompletedNot Applicable
Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity
United States18 participantsStarted 2024-03-25
Plain-language summary
The goal of this study is to see the effect that a cooling pillow pad called Moona has on sleep quality.
Who can participate
Age range
21 Years – 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:
* African American men and women
* Aged 21-50 years
* BMI ≥ 27 to 45 kg/m2
* Self-report of short or poor sleepers (\>5 \< 7hrs /night and/or a score \> 5 on the PSQI),
* Sleeping between 22:00 and 08:00.
* Ability to provide informed consent before any trial-related activities
* Controlled hypertension or dyslipidemia.
Exclusion Criteria:
* Previous diagnosis or reveled during the screening PSG (Polysomnography) of obstructive sleep apnea (AHI≥30) or other sleep disorders based on DSM-V (Diagnostic and Statistical Manual of Mental Disorders, fifth edition) criteria.
* Shift work
* Diagnosis of diabetes based on history or screening tests
* History of cognitive or other neurological disorders
* History of major psychiatric disorder based on DSM-V criteria
* Presence of unstable or serious medical conditions
* Use within the past month of melatonin, psychoactive, hypnotic, stimulant or pain medications (except occasionally)
* Caffeine consumption of greater than 500 mg per day
* Medically managed weight loss program within the past 6 months
* History of bariatric weight loss surgery.
* Women who are pregnant, plan on becoming pregnant, are breastfeeding,
* Men or women who have a child at home that does not sleep through the night.
* Active drug/alcohol dependence or abuse
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
Sleep Outcome-Time to sleep onset
Timeframe: Baseline to Day 22
2
Sleep Outcome- Wake time
Timeframe: Baseline to Day 22
3
Sleep Outcome- Sleep microarousals
Timeframe: Baseline to Day 22
4
Sleep Outcome- Sleep duration
Timeframe: Baseline to Day 22
5
Change in Sleep duration from baseline to day 22
Timeframe: Baseline to Day 22
6
Sleep Outcome- Regularity of sleep
Timeframe: Baseline to Day 22
7
Sleep Outcome- Sleep efficiency
Timeframe: Baseline to Day 22
8
Change in sleep efficiency from baseline to day 22