Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity

Launched by UNIVERSITY OF CHICAGO · Apr 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a special cooling pillow pad called Moona to see how it affects sleep quality in African American adults who are overweight or obese. The researchers want to find out if using this cooling technology can help people sleep better. They are currently looking for participants aged 21 to 50 who have a body mass index (BMI) of 27 to 45 and report having trouble sleeping, which means they typically get less than 7 hours of sleep a night or have poor sleep quality.

To join the study, you must be an African American man or woman within the specified age range and meet certain health criteria, such as having controlled blood pressure or cholesterol levels. However, if you have certain sleep disorders, diabetes, or serious medical conditions, or if you use specific medications or substances, you may not be eligible. Participants can expect to use the cooling pillow pad during the study and share feedback on their sleep. This trial aims to understand if this innovative approach can help improve sleep for those struggling with it.

Gender

ALL

Eligibility 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