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

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

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

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Device: Moona Device; Device: Inactive Moona Device

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Moona Device; Moona Device pillow pad
Sham Comparator: 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.	Device: Inactive Moona Device; Inactive Moona Device pillow pad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Outcome-Time to sleep onset	A decrease in time to sleep onset from baseline to day 22 measured in time of day by Wrist Actigraphy Monitoring.	Baseline to Day 22
Sleep Outcome- Wake time	Change in wake time from baseline to day 22 measured in time of day by Wrist Actigraphy Monitoring.	Baseline to Day 22
Sleep Outcome- Sleep microarousals	Change in wake time from baseline to day 22 measured by polysomnography. The index is generated by polysomnography software.	Baseline to Day 22
Sleep Outcome- Sleep duration	Change in Sleep duration from baseline to day 22 measured in minutes by Wrist Actigraphy Monitoring.	Baseline to Day 22
Change in Sleep duration from baseline to day 22	Sleep duration measured in minutes by polysomnography.	Baseline to Day 22
Sleep Outcome- Regularity of sleep	Change in regularity of sleep from baseline to day 22 measured by Wrist Actigraphy Monitoring. The value is from standard deviation of time of middle of the sleep period.	Baseline to Day 22
Sleep Outcome- Sleep efficiency	Change in sleep efficiency from baseline to day 22 measure by a percentage of total sleep time/time in bed from Wrist Actigraphy Monitoring.	Baseline to Day 22
Change in sleep efficiency from baseline to day 22	Sleep efficiency measure by a percentage of total sleep time/time in bed from polysomnography.	Baseline to Day 22
Change in glucose homeostasis after 22 days of Moona Device usage.	The Matsuda Index of whole body insulin sensitivity, the homeostasis model assessment (HOMA) measures beta cell function and insulin resistance. These changes in glucose homeostasis from baseline to 22 days of Moona Device usage are measured by Oral glucose tolerance test (OGTT).	through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline through day 22 of novel Patient Reported Outcome instrument	Detection of within-patient changes in sleep effects reported in a novel Patient-Reported Outcome instrument between baseline and Day 22.	Baseline to Day 22
Changes in the perception of sleep quality from baseline through day 22	Detection of within-patient change in the perception of sleep quality reported in a novel Patient-Reported Outcome instrument between baseline and Day 22.	Baseline to Day 22
Pre-sleep and durational sleep secretion of melatonin values at days 7-8 and days 21-22.	Urine samples will be collected at two timepoints before bedtime and in the morning. The secretion of melatonin at these timepoints will result in a numerical value.	through study completion, an average of 1 month
Glucose Homeostasis-First phase insulin response	Changes in first phase insulin response (ARIg=mu.i^-1.min) from baseline to Day 22 measured by oral glucose tolerance test (OGTT).	Baseline to Day 22
Glucose Homeostasis- insulinogenic index	Changes in insulinogenic index (change in plasma insulin/change in plasma glucose from 0-30 minutes = (pmol/L)/(mg/dL)) from baseline to Day 22 measured by oral glucose tolerance test (OGTT).	Baseline to Day 22
Glucose Homeostasis- Mean Absolute Glucose	Changes in Mean Absolute Glucose (MAG - mg/dl) from baseline to Day 22 measured by Continuous Glucose Monitoring System (CGMS).	Baseline to Day 22
Glucose Homeostasis- Coefficient of Variation	Changes in Coefficient of Variation (CV - mg/dl) from baseline to Day 22 measured by Continuous Glucose Monitoring System (CGMS).	Baseline to Day 22
Glucose Homeostasis- Standard Deviation	Changes in Standard Deviation (SD-mg/dl) from baseline to Day 22 measured by Continuous Glucose Monitoring System (CGMS).	Baseline to Day 22
Glucose Homeostasis- Area Under the Curve	Changes in Area Under the Curve (AUC - mg/dl) from baseline to Day 22 measured by Continuous Glucose Monitoring System (CGMS).	Baseline to Day 22
Glucose Homeostasis- Time Spent in Range	Changes in Time Spent in Range (TIR - minutes) from baseline to Day 22 measured by Continuous Glucose Monitoring System (CGMS).	Baseline to Day 22
Glucose Homeostasis- Continuous Overall Net Glycemic Action	Changes in Continuous Overall Net Glycemic Action (CONGA - (mg/dl) per minutes) from baseline to Day 22 measured by Continuous Glucose Monitoring System (CGMS).	Baseline to Day 22
Glucose-stimulated insulin release inhibition of lipolysis, measured by free fatty acids (FFA) value and oral glucose tolerance test (OGTT).	The rate of FFA decline will be estimated as a measure of insulin sensitivity at the level of the adipocyte.	through study completion, an average of 1 month
Area under the curve Glucose-dependent insulinotropic polypeptide (GIP) concentrations glucose-dependent insulinotropic polypeptide (GIP) concentrations by oral glucose tolerance test (OGTT).	GIP levels, secreted by the K cells in the small intestine is an incretin hormone that is released in response to food ingestion and stimulates insulin release. The OGTT will provide these GIP levels.	through study completion, an average of 1 month
Weight in kg, measured from screening through study completion.	The change in weight values will be measured by blind scales and anthropometrics measurements.	through study completion, an average of 1 month
Glucose Homeostasis-Oral disposition index (DIo)	Changes in oral disposition index (DIo) from baseline to Day 22 measured in (SI x ARIg = [(mu/l)^-1.min^-1] * [mu.l^-1.min]) by oral glucose tolerance test (OGTT).	Baseline to Day 22

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Silvana Pannain, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Actual): August 12, 2025
• Study Completion (Actual): August 12, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: IRB22-1546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study aggregate results will be shared with Moona. No raw data, individual study records or identifying information will be shared outside of the University of Chicago study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes