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

Overweight or Obesity Clinical Trial

— Moona  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849181
• Other study ID #: IRB22-1546
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: Silvana Pannain, MD
• Phone: 773-702-3275
• Email: spannain[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight or Obesity

Intervention

Device:
• Moona Device
Moona Device pillow pad
• Inactive Moona Device
Inactive Moona Device pillow pad

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Sleep Outcome- Sleep duration	Change in Sleep duration from baseline to day 22 measured in minutes by Wrist Actigraphy Monitoring.	Baseline to Day 22
Primary	Change in Sleep duration from baseline to day 22	Sleep duration measured in minutes by polysomnography.	Baseline to Day 22
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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