Localized Body Cooling for Obesity (Moona Trial)

N/A

Recruiting

Led By Silvana Pannain, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 month

Summary

This trial will test if using a cooling pad called Moona helps improve sleep quality.

Who is the study for?

This trial is for African American men and women aged 21-50 with a BMI of 27 to 45 kg/m2 who often get poor sleep (5-7 hours per night or have high PSQI scores). Participants should not have severe sleep apnea, other major sleep disorders, diabetes, neurological or psychiatric conditions, consume excessive caffeine, be pregnant/breastfeeding, or have young children that disrupt sleep.

What is being tested?

The study tests the Moona Device—a cooling pillow pad—against an inactive version to see if it improves sleep quality in participants. The goal is to determine whether localized body cooling at night can positively affect both rest and metabolism in individuals with overweight and obesity.

What are the potential side effects?

Since this trial involves a non-invasive device designed to cool the sleeping area rather than medication, side effects are expected to be minimal. However, discomfort due to temperature changes or potential skin irritation from the device could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Sleep duration from baseline to day 22

Change in glucose homeostasis after 22 days of Moona Device usage.

Change in sleep efficiency from baseline to day 22

+6 more

Secondary study objectives

Area under the curve Glucose-dependent insulinotropic polypeptide (GIP) concentrations glucose-dependent insulinotropic polypeptide (GIP) concentrations by oral glucose tolerance test (OGTT).

Changes from baseline through day 22 of novel Patient Reported Outcome instrument

Changes in the perception of sleep quality from baseline through day 22

+12 more