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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Overweight or Obesity

Intervention / Treatment
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* Device: Moona Device
* Device: Inactive Moona Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subject are randomized to either treatment or placebo arm.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moona Active Group<br>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<br>* Moona Device pillow pad<br>|
| Sham Comparator: Moona Inactive Group<br>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<br>* Inactive Moona Device pillow pad<br>|

What is the study measuring?
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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-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 | 
| 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 |