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

NCT05849181 | Completed FDA Device

• 1 other identifier: IRB22-1546
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (15)

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

  Baseline to Day 22

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

  Baseline to Day 22

• Pre-sleep and durational sleep secretion of melatonin values at days 7-8 and days 21-22.

  through study completion, an average of 1 month

• Glucose Homeostasis-First phase insulin response

  Baseline to Day 22

• Glucose Homeostasis-Oral disposition index (DIo)

  Baseline to Day 22

Study Arms (2)

Moona Active Group

ACTIVE COMPARATOR

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 Inactive Group

SHAM COMPARATOR

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

Interventions

Moona Device DEVICE

Moona Device pillow pad

Moona Active Group

Inactive Moona Device DEVICE

Inactive Moona Device pillow pad

Moona Inactive Group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvana Pannain, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participant, Care provider and Investigator blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subject are randomized to either treatment or placebo arm.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 8, 2023
• Study Start: March 25, 2024
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)