跳至主要内容
临床试验/NCT05636930
NCT05636930招募中不适用

To Evaluate the Accuracy of Sleep Parameters Evaluated by Wearable Sleep Devices

Shanshan Lu1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Accuracy of sleep parameters of wearable devices

研究概览

简要总结

As a necessary process of life, sleep is an important link for the body to recover, integrate and consolidate memory. However, the fast pace of life in modern society and people's bad living habits are easy to cause sleep disorders. Sleep disorders are often the main factors that induce or aggravate cardiovascular and cerebrovascular diseases. Sleep staging is an important basis for sleep quality assessment and related disease diagnosis. At present, electroencephalography (EEG) has become the gold standard for judging sleep stages. However, this kind of method requires long-term contact of multiple electrodes with the human body, which is easy to affect the natural sleep of the subjects, so it is not suitable for sleep monitoring in home environment. Studies have shown that sleep is related to the regulation of autonomic nervous system, and heart rate variability (HRV) in sleep also shows periodic changes similar to brain waves. Smartwatch/bracelet can continuously monitor the user's pulse wave and acceleration data comfortably and without feeling. HRV features can be extracted using pulse wave data, and then sleep staging can be realized based on the correlation between HRV and brain waves, and sleep quality can be evaluated. Therefore, healthy sleep research aims to use smart devices to achieve sleep monitoring in the home environment and improve people's sleep quality

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • a. Adults aged 18 and above and under the age of 60; The age of the subjects was divided into two age groups: 18-44, 45-60, and the ratio between the two groups was 1:1.2-1:0.
  • The ratio of female to male is between 1:1.1 and 1:1.0; b. No patients with serious cardiovascular and cerebrovascular diseases, moderate degree of depression, anxiety disorder or severe apnea; HAMD<=20;HAMA <=13;AHI< 30 c. Subjects did not drink alcohol or take sleep intervention drugs during the program; d. People with sleep disorders and insomnia can be included in the subjects, but the total number is no more than 50%, and should be clearly marked; e. Having Chinese nationality and residing in China; f. Agree to be monitored by PSG and wear wearable devices; Voluntary entry, informed consent or consent to privacy agreement.

排除标准

  • a. Patients with a history of depression, anxiety and other mental disorders; HAMD>20;HAMA>13 b. Patients with existing atherosclerotic cardiovascular diseases, such as coronary heart disease and severe peripheral atherosclerotic disease; c. age >60 d. Patients with obstructive sleep apnea (AHI >30); Use of drugs or substances affecting the central nervous system in the preceding 2 weeks.

结局指标

主要结局

Accuracy of sleep parameters of wearable devices

时间窗: 8-10AM

Sleep Latency,sleep efficiency

次要结局

未报告次要终点

研究者

发起方
Shanshan Lu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shanshan Lu

Doctor of Medicine(M.D.)

Qianfoshan Hospital

研究点 (1)

Loading locations...

相似试验