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临床试验/NCT02463461
NCT02463461撤回不适用

Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

Weill Medical College of Cornell University0 个研究点开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Total sleep time (TST)

研究概览

简要总结

The primary objective of the proposed study is to investigate the agreement levels of modern and well-established actigraphy devices against PSG in healthy as well as patient populations for multiple sleep parameters across two study sites (Qatar and New York City).

详细描述

The importance of sleep upon physiological and psychological health has been extensively documented. It has been proposed that adequate sleep, as well as good sleep quality, is vital for wellbeing. (1). Some have suggested that sleep curtailment has paralleled the increased prevalence of cardiometabolic disease including obesity (2), type 2 diabetes mellitus (3, 4), hypertension (5, 6) and more. Sleep researchers face a major challenge since there are multiple methods for sleep assessment, all of which have advantages and disadvantages.Whilst polysomnography (PSG) is considered to be the gold standard for sleep assessment, there are some limitations including laboratory attendance for the participant and sleep scoring variance. Sleep questionnaires are widely utilized, particularly in large epidemiological studies, but are susceptible to inaccuracies and some have not been validated against PSG. Wrist actigraphy has provided researchers with an attractive equivalent and there are now multiple commercial manufacturers available. Actigraphic devices are usually worn on the non-dominant wrist and the instrument is used to monitor wrist movements through the use of an accelerometer and a memory chip. Wrist actigraphy is useful in the detection of sleep, wake, and activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Male or female. 18-80 years old

排除标准

  • Not attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Under 18 or over 80 years old. Pregnancy. Unable to provide informed consent.

结局指标

主要结局

Total sleep time (TST)

时间窗: 1 night

The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.

次要结局

  • Wake After Sleep Onset (WASO)(1 Year)

研究者

申办方类型
Other
责任方
Sponsor

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