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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Sleep Outcome- Sleep duration
研究概览
简要总结
The goal of this study is to see the effect that a cooling pillow pad called Moona has on sleep quality.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participant, Care provider and Investigator blinded
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Ability to provide informed consent before any trial-related activities
- •Controlled hypertension or dyslipidemia.
排除标准
- •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
结局指标
主要结局
Sleep Outcome- Sleep duration
时间窗: Baseline to Day 22
Change in Sleep duration from baseline to day 22 measured in minutes by Wrist Actigraphy Monitoring.
Change in Sleep duration from baseline to day 22
时间窗: Baseline to Day 22
Sleep duration measured in minutes by polysomnography.
Sleep Outcome-Time to sleep onset
时间窗: Baseline to Day 22
A decrease in time to sleep onset from baseline to day 22 measured in time of day by Wrist Actigraphy Monitoring.
Sleep Outcome- Regularity of sleep
时间窗: Baseline to Day 22
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.
Sleep Outcome- Wake time
时间窗: Baseline to Day 22
Change in wake time from baseline to day 22 measured in time of day by Wrist Actigraphy Monitoring.
Change in glucose homeostasis after 22 days of Moona Device usage.
时间窗: through study completion, an average of 1 month
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).
Sleep Outcome- Sleep microarousals
时间窗: Baseline to Day 22
Change in wake time from baseline to day 22 measured by polysomnography. The index is generated by polysomnography software.
Sleep Outcome- Sleep efficiency
时间窗: Baseline to Day 22
Change in sleep efficiency from baseline to day 22 measure by a percentage of total sleep time/time in bed from Wrist Actigraphy Monitoring.
Change in sleep efficiency from baseline to day 22
时间窗: Baseline to Day 22
Sleep efficiency measure by a percentage of total sleep time/time in bed from polysomnography.
次要结局
- Changes from baseline through day 22 of novel Patient Reported Outcome instrument(Baseline to Day 22)
- Pre-sleep and durational sleep secretion of melatonin values at days 7-8 and days 21-22.(through study completion, an average of 1 month)
- Glucose Homeostasis- Coefficient of Variation(Baseline to Day 22)
- Glucose Homeostasis- Standard Deviation(Baseline to Day 22)
- Glucose Homeostasis- Mean Absolute Glucose(Baseline to Day 22)
- Glucose Homeostasis- Time Spent in Range(Baseline to Day 22)
- Weight in kg, measured from screening through study completion.(through study completion, an average of 1 month)
- Glucose Homeostasis-First phase insulin response(Baseline to Day 22)
- Glucose Homeostasis- insulinogenic index(Baseline to Day 22)
- Glucose Homeostasis- Area Under the Curve(Baseline to Day 22)
- Changes in the perception of sleep quality from baseline through day 22(Baseline to Day 22)
- Glucose Homeostasis-Oral disposition index (DIo)(Baseline to Day 22)
- Glucose Homeostasis- Continuous Overall Net Glycemic Action(Baseline to Day 22)
- Glucose-stimulated insulin release inhibition of lipolysis, measured by free fatty acids (FFA) value and oral glucose tolerance test (OGTT).(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).(through study completion, an average of 1 month)