NCT05849181

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Moona Device	Moona Device pillow pad
DEVICE	Inactive Moona Device	Inactive Moona Device pillow pad

Timeline

• Start date: 2024-03-25
• Primary completion: 2025-08-12
• Completion: 2025-08-12
• First posted: 2023-05-08
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study