Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:
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
- Total sleep time (TST)
研究概览
简要总结
The study aims to examine the effects of a sleep extension intervention on the metabolic and cardio-vascular profile of obese people who present traditional diabetes risk factors, and who are habitually sleep deprived. Participants randomized to the intervention arm will complete a 6-week sleep extension intervention, whilst the control group will maintain their habitual sleep schedule. It is hypothesized that the sleep extension intervention will significantly increase total sleep time, and will be accompanied by significant metabolic-related changes.
详细描述
Recent epidemiological (survey) research, conducted in both in healthy populations and among those with existing chronic disease, shows that insufficient sleep can significantly contribute to ill health (including diabetes, heart disease and obesity). These findings have also been accompanied by credible explanatory mechanisms emphasising the role of sleep in regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a largely unexplored pathway for improving individual health, and reducing an existing risk of diabetes. If successful, increased sleep duration and quality could be adopted as an achievable public health intervention.
The study aims to recruit a total of 20 men, overweight, presenting traditional risks of developing diabetes, who are habitually short sleepers. Participants are then randomized, stratified by weight status, to a sleep extension group, or a control sleep monitoring group. Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure, and a mixed-meal tolerance test; after the 6-week intervention, the same measures are repeated.
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
- Single (Outcomes Assessor)
盲法说明
Blood samples outcome assessor was blinded to group allocation.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: 25 to 55 years (inclusive)
- •Gender: Men
- •BMI > 25kg/m2
- •Average self-reported sleep duration of ≤ 6h per 24h
- •Stable daily sleep/wake schedule
- •Health risk screening score ≥ 2
排除标准
- •Diagnosed sleep disorder as per DSM-5: e.g. insomnia, restless legs syndrome, moderate/severe Obstructive Sleep Apnoea; Epworth Sleepiness Score: <5
- •Diagnosed chronic conditions, or medication, likely to interfere with regular sleep: T2D, chronic fatigue syndrome, fibromyalgia, COPD, uncontrolled depression/anxiety, other severe psychiatric illness, substance abuse.
- •Night/evening shift work , regular time-zone travel, other circumstances preventing regular sleep schedule (e.g. very young children, carer at night for sick relatives etc)
结局指标
主要结局
Total sleep time (TST)
时间窗: 24 hours
Time asleep obtained every night, as measured by actigraphy (minutes).
次要结局
- Sleep onset latency (SOL)(24 hours)
- Time in Bed (TIB)(24 hours)
- Wake after sleep onset (WASO)(24 hours)
- Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose(14 days)
- Total PYY concentration(3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes)
- Grelin concentration(3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes)
- Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)(24 hours)
- Insulin concentration(3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes)
- Multidimensional Assessment of Fatigue(One week)
- Glucose concentration(3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes)
- Leptin concentration(8-hour fasting blood samples)
- Mean Amplitude of Glycemic Excursions(24 hours)
- Systolic and diastolic blood pressure(10 minutes)
- Pittsburgh Sleep Quality Index(One month)
研究者
Dr Iuliana Hartescu
Lecturer in Psychology
Loughborough University