A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Wake After Sleep Onset, WASO
研究概览
简要总结
70 overweight or obese adults with sleep disorders will be recruited for this study, in which the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters derived from this actigraphy.
详细描述
As an observation study, it will recruit 70 overweight or obese patients with sleep disorders who meet the selection criteria: clinical records and AIS at a tertiary hospital. The patients will sign the informed consent form. The involved patients and doctors will receive related training.
These patients will receive the sleep monitoring from 21:00 to 6:00 in sleep monitoring laboratory in Ruijin Hospital. They will receive the PSG and Jawbone Up 2 sleep monitoring at the same time. Sleep parameters derived from actigraphy and PSG will be compared in multiple night recordings such as total sleep time, wake after sleep onset, sleep onset latency, awakening, sleep efficiency, total time in bed,. The aim is to assess the validation of actigraphy in overweight or obese patients with sleep disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Have one or more sleep disorders such as consecutive snoring, insomnia, sleep apnea, narcolepsy, delayed sleep phase syndrome
- •Athens Insomnia Scale (AIS)>6
- •Agree to participate in the study and have signed the inform consent form
排除标准
- •Terminal illness
- •Physically-challenged and paralyzed patients
- •Intend to receive selective surgery, to get pregnancy and breast feeding in three months
- •Long-term use of the sleeping pills
- •Hearing loss or severe visual disorder;
- •Mental disorders
- •Dementia or communication disorders
- •Unable to complete an all night sleep monitoring
结局指标
主要结局
Wake After Sleep Onset, WASO
时间窗: 10 hrs
Total Sleep Time, TST
时间窗: 10 hrs
次要结局
- Sleep Onset Latency, SOL(10 hrs)
- Frequency of arousal during sleep,awakenings(10 hrs)
- Sleep Efficiency, SE(10 hrs)
研究者
Guang Ning
Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine