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

University of Chicago18 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Overweight or Obesity

Interventions

Moona DeviceDEVICE

Moona Device pillow pad

Inactive Moona DeviceDEVICE

Inactive Moona Device pillow pad

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Day 22

Sleep Outcome- Sleep duration

Change in Sleep duration from baseline to day 22 measured in minutes by Wrist Actigraphy Monitoring.

Time frame: Baseline to Day 22

Change in Sleep duration from baseline to day 22

Sleep duration measured in minutes by polysomnography.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Day 22

Change in sleep efficiency from baseline to day 22

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: through study completion, an average of 1 month