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Localized Body Cooling for Obesity (Moona Trial)

N/A
Waitlist Available
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
Awards & highlights

Moona Trial 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.Check my eligibility
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.See study design
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.

Moona Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Moona Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Moona Active GroupActive Control1 Intervention
Participants in the Moona Active Group will placed the device between the pillow and the pillow cover, under their head and neck.
Group II: Moona Inactive GroupPlacebo Group2 Interventions
Participants in the Moona Inactive Group will placed the device between the pillow and the pillow cover, under their head and neck.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,834 Total Patients Enrolled
14 Trials studying Obesity
1,970 Patients Enrolled for Obesity
Silvana Pannain, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Moona Device (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05849181 — N/A
Obesity Research Study Groups: Moona Active Group, Moona Inactive Group
Obesity Clinical Trial 2023: Moona Device Highlights & Side Effects. Trial Name: NCT05849181 — N/A
Moona Device (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05849181 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria make someone an ideal candidate for this research?

"In order to qualify, prospective participants must have a BMI over the obesity threshold and be between 21 and 50 years old. Approximately 20 people are required for this research project."

Answered by AI

Do adults over 40 qualify for this experiment?

"This study is currently recruiting patients whose age lies between 21 and 50. In contrast, there are 219 trials for minors and 714 studies that cater to those over 65 years of age."

Answered by AI

Are new enrollees still being accepted for this clinical investigation?

"According to the resources available on clinicaltrials.gov, this research is not presently enrolling participants. The trial was first registered on June 1st 2023 and has since had a minor update about three months later in April 27th 2023. However, there are 1165 other studies actively searching for patients at this time."

Answered by AI

What are the expected outcomes of this clinical trial?

"The investigation's chief endpoint, which will be monitored from Baseline to Day 22 is Sleep Outcome- Wake time. Other assessments include a Patient-Reported Outcome study of sleep quality variations between baseline and day 22, urinary melatonin levels pre-sleep and post-wake at days 7/8 and 21/22 respectively, plus alterations in first phase insulin response (ARIg=mu.i^-1.min) as measured by an oral glucose tolerance test (OGTT)."

Answered by AI

Who else is applying?

What site did they apply to?
University of Chicago
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I need help to get rid of my fat cells.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity
2024. "Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05849181.
~11 spots leftby Apr 2025
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