NCT02787577已完成不适用
The SLuMBER Study: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Sleep Duration
研究概览
简要总结
Short sleep duration has been associated with increased risk of weight gain and development of non-communicable diseases. Sleep deprivation studies have suggested the link between restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal. However, the severity and acuteness of sleep restriction schedules in laboratory-based studies could hinder the ecological validity of the findings. The pragmatic way forward is to assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes. This study assesses the feasibility of lengthening sleep in short sleepers, as well as how improved sleep duration and/or quality impact metabolic health, body composition, energy balance and cardiovascular risk.
详细描述
Research Questions
- Is it feasible to improve sleep duration and quality in habitually short sleepers under free-living conditions?
- What are the effects of improved sleep duration and quality on body composition, energy balance, dietary intake, and cardio-metabolic risk factors?
Hypothesis
- Improved sleep duration and/or quality in habitually short sleepers will result in improved energy balance, diet quality, body composition, and cardio-metabolic risk profile.
Aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults (18-64 years)
- •Habitually short sleepers (5-<7 hours of sleep per night on average on weekdays) - this is self-reported at screening, and confirmed by actigraphy when baseline measurement is taken.
- •BMI: 18.5 - <30
排除标准
- •Diagnosed medical conditions such as:
- •Cardiovascular disease
- •Type 1 or Type 2 Diabetes Mellitus
- •Cancer (excluding basal carcinoma) in the past five years
- •Chronic renal or liver disease
- •Inflammatory bowel disease
- •Hypo/hyperthyroidism
- •Sleep conditions:
- •Chronic use of sleeping aid medication
- •Insomnia (Insomnia Severity Index - ISI Questionnaire)
- •Sleep apnoea (Berlin Questionnaire)
- •Extreme Chronotype (HorneOstberg questionnaire)
- •Pregnancy or lactation
- •Weight change of >3 kg in the previous two months
- •Previous or current high alcohol intake (>28 units/week for males and >21 units/week for females) or substance abuse
- •Working hours outside 7 am - 7 pm
- •Habitual napping (>20 minutes per day on a regular basis)
- •Obliged to wake and care for family/friends (e.g. new born child etc)
- •Use of antidepressants
- •Depressed mood (Center of Epidemiologic Studies of Depression 20-item scale questionnaire)
- •Travel arrangements outside time zone within the periods of data collection
- •Travel arrangements outside time zone within period of intervention/control condition
- •Inability to adhere to a sleep hygiene intervention/sleep schedule due to time commitments
结局指标
主要结局
Sleep Duration
时间窗: week 4
Wrist Actigraphy
Sleep Quality
时间窗: week 4
Wrist Actigraphy
次要结局
- Blood pressure(day 28)
- Fasting triglycerides(day 28)
- plasma leptin(day 28)
- plasma cortisol(day 28)
- Fasting blood glucose(day 28)
- Body fat percentage(day 28)
- plasma insulin(day 28)
- Digital volume pulse - Reflection Index (RI)(day 28)
- Dietary Intake (7-day food diary)(week 4)
- Sleep Hygiene Index (SHI)(day 28)
- BMI(day 28)
- Fasting total cholesterol(day 28)
- Fasting HDL cholesterol(day 28)
- plasma ghrelin(day 28)
- Homeostasis model assessment estimated insulin resistance (HOMA-IR)(day 28)
- Waist circumference(day 28)
- Lean body mass(day 28)
- Digital volume pulse - Stiffness Index (SI)(day 28)
- Urinary 6-sulphatoxymelatonin(day 28)
- Recent Physical Activity Questionnaire (RPAQ)(day 28)
- Fasting LDL cholesterol(day 28)
- Hip circumference(day 28)
- Resting Metabolic Rate (RMR)(day 28)
- Mnemonic Similarity Test (MST)(day 28)
- Total Energy Expenditure (TEE)(day 21-23)
- Eating Choices Index (ECI)(day 28)
- Pittsburgh Sleep Quality Index (PSQI)(day 28)
研究者
研究点 (2)
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