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

NCT ID: NCT05849181

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2025-08-12

Brief Summary

The goal of this study is to see the effect that a cooling pillow pad called Moona has on sleep quality.

Detailed Description

Obesity and diabetes pose a significant burden on healthcare systems worldwide. Evidence from large cross-sectional and longitudinal epidemiologic studies, and well-designed experimental sleep manipulations, demonstrated that insufficient sleep is a risk factor for obesity-induced insulin resistance and type 2 diabetes. Limited available evidence suggests that optimizing sleep duration and quality in individuals who experience deficient sleep could have beneficial effects on weight maintenance, facilitate weight loss and improve glucose metabolism. It is well known that body temperature impacts sleep. A rapid decline in core body temperature increases the likelihood of sleep initiation and may facilitate an entry into the deeper stages of sleep.

Pharmacological treatment is often prescribed for sleep disturbances, primarily insomnia. But sleep extension with benzodiazepines/sedative-hypnotic agents does not appear to have beneficial effects on metabolism, in fact, these drugs may even have an adverse effect on glucose metabolism. Many people use melatonin as a sleep aid, however, the available data do not support a major role of melatonin in body weight regulation and the evidence supporting melatonin administration in improving glucose metabolism has been mixed.

Limited studies suggest that localized cooling could represent a non-pharmacological strategy to favor sleep onset or improve sleep duration and/or quality.

Conditions

Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Moona Active Group

Participants in the Moona Active Group will placed the device between the pillow and the pillow cover, under their head and neck.

Group Type: ACTIVE_COMPARATOR

Moona Device

Intervention Type: DEVICE

Moona Device pillow pad

Moona Inactive Group

Participants in the Moona Inactive Group will placed the device between the pillow and the pillow cover, under their head and neck.

Group Type: SHAM_COMPARATOR

Inactive Moona Device

Intervention Type: DEVICE

Inactive Moona Device pillow pad

Interventions

Moona Device

Moona Device pillow pad

Intervention Type: DEVICE

Inactive Moona Device

Inactive Moona Device pillow pad

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvana Pannain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB22-1546

Identifier Type: -

Identifier Source: org_study_id