Cooling technology to improve sleep and metabolism in overweight African Americans
Randomized Double-Blind Pilot Study to Examine the Effects of a Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity
This study is testing if a cooling device can help overweight African Americans sleep better and improve their metabolism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05849181 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a localized cooling device called Moona on sleep quality among African American individuals with overweight or obesity. It aims to determine whether optimizing sleep through body cooling can enhance sleep duration and quality, potentially leading to better weight management and improved glucose metabolism. Participants will be monitored for changes in sleep patterns and metabolic health while using the Moona device compared to an inactive version. The study focuses on individuals who report poor sleep and have a BMI within a specified range.
Who should consider this trial
Good fit: Ideal candidates are African American men and women aged 21-50 with a BMI between 27 and 45 who experience short or poor sleep.
Not a fit: Patients with diagnosed sleep disorders, such as obstructive sleep apnea, or those with significant medical or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological method to improve sleep quality and metabolic health in overweight individuals.
How similar studies have performed: Limited studies have suggested that localized cooling may improve sleep, but this specific approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Silvana Pannain, MD — University of Chicago
- Study coordinator: Silvana Pannain, MD
- Email: spannain@bsd.uchicago.edu
- Phone: 773-702-3275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.