Clinical trial NCT05849181: Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight or Obesity
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subject are randomized to either treatment or placebo arm.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep Outcome-Time to sleep onset
timeFrame: Baseline to Day 22
measure: Sleep Outcome- Wake time
timeFrame: Baseline to Day 22
measure: Sleep Outcome- Sleep microarousals
timeFrame: Baseline to Day 22
measure: Sleep Outcome- Sleep duration
timeFrame: Baseline to Day 22
measure: Change in Sleep duration from baseline to day 22
timeFrame: Baseline to Day 22
measure: Sleep Outcome- Regularity of sleep
timeFrame: Baseline to Day 22
measure: Sleep Outcome- Sleep efficiency
timeFrame: Baseline to Day 22
measure: Change in sleep efficiency from baseline to day 22
timeFrame: Baseline to Day 22
measure: Change in glucose homeostasis after 22 days of Moona Device usage.
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Changes from baseline through day 22 of novel Patient Reported Outcome instrument
timeFrame: Baseline to Day 22
measure: Changes in the perception of sleep quality from baseline through day 22
timeFrame: Baseline to Day 22
measure: Pre-sleep and durational sleep secretion of melatonin values at days 7-8 and days 21-22.
timeFrame: through study completion, an average of 1 month
measure: Glucose Homeostasis-First phase insulin response
timeFrame: Baseline to Day 22
measure: Glucose Homeostasis-Oral disposition index (DIo)
timeFrame: Baseline to Day 22
measure: Glucose Homeostasis- insulinogenic index
timeFrame: Baseline to Day 22
measure: Glucose Homeostasis- Mean Absolute Glucose
timeFrame: Baseline to Day 22
measure: Glucose Homeostasis- Coefficient of Variation
timeFrame: Baseline to Day 22
measure: Glucose Homeostasis- Standard Deviation
timeFrame: Baseline to Day 22
measure: Glucose Homeostasis- Area Under the Curve
timeFrame: Baseline to Day 22
measure: Glucose Homeostasis- Time Spent in Range
timeFrame: Baseline to Day 22
measure: Glucose Homeostasis- Continuous Overall Net Glycemic Action
timeFrame: Baseline to Day 22
measure: Glucose-stimulated insulin release inhibition of lipolysis, measured by free fatty acids (FFA) value and oral glucose tolerance test (OGTT).
timeFrame: through study completion, an average of 1 month
measure: Area under the curve Glucose-dependent insulinotropic polypeptide (GIP) concentrations glucose-dependent insulinotropic polypeptide (GIP) concentrations by oral glucose tolerance test (OGTT).
timeFrame: through study completion, an average of 1 month
measure: Weight in kg, measured from screening through study completion.
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Silvana Pannain, MD
role: PRINCIPAL_INVESTIGATOR
References: