PSG Validation Study of Zensorium Biosensing Wearable Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- polysomnography derived percent REM and percent non-REM sleep
研究概览
简要总结
The objective of this study is to collect data comparing the Zensorium Biosensing Wearable Device (zBWD) to polysomnography (PSG) in individuals with Sleep-Wake Disorders. zBWD is similar to other wearable devices (e.g., fitbit and apple watch) that use an optical light sensor and Tri-axis Accelerometer to record steps, activity, sleep/awake states, sleep staging, and statistical variation of pulse pressure to track stress. Specifically, it is designed to report sleep duration, non-rapid eye movement (NREM) and REM sleep duration. However, zBWD has not been validated against PSG for sleep tracking in healthy controls or in individuals with sleep-wake disorders.
详细描述
Subjects known to have or not have sleep-wake disorder, as well as healthy subjects, will be enrolled if they otherwise meet all the inclusion criteria, and none of the exclusion criteria. Subject will be asked to complete several questionnaires and wear the zBWD for 7-days, in an off-site (Home) study, followed by a single overnight PSG study to compare the zBWD data to the current gold standard of PSG. Subjects who have completed the study will also be sent a letter thanking them for their participation and offering a summary of the results of their sleep study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Health status: Healthy, or those with sleep-wake disorders
排除标准
- •Currently smoking
- •Any respiratory disorder other than associated with Sleep/Wake Disorder or well-controlled asthma
- •Habitual use of medications known to affect respiratory function (e.g. opioids, benzodiazepines, etc).
- •Use of medication known to affect pulse pressure (Beta Blockers)
- •Atrial Fibrillation
- •Tattoos located on wrist
结局指标
主要结局
polysomnography derived percent REM and percent non-REM sleep
时间窗: One overnight stay at Visit 2 (7 - 10 days following Baseline)
A full clinical overnight polysomnography (PSG) study will be performed 7 - 10 days following visit 1. The subject will have EEG, EMG, EOG, and ECG electrodes, an adhesive body position sensor placed in standard locations. This equipment is standard for diagnostic PSG. The variables of interest from the PSG are stages of sleep as indicated by PSG including % rapid eye movement (REM; amount of time in REM sleep/Total sleep time) and % non-REM (amount of time in non-REM sleep/Total sleep time)
Zensorium derived percent REM and percent Non-REM sleep
时间窗: To be worn everyday between Baseline to visit 2 (7 -10 days)
Zensorium Biosensing Wearable Device (zBWD) will be worn for 7 to 10 days following visit 1. The variables of interest are stages of sleep as indicated by the zBWD including % rapid eye movement (REM; amount of time in REM sleep/Total sleep time) and % non-REM (amount of time in non-REM sleep/Total sleep time).
次要结局
- Sleep Diary(To be filled out everyday between Baseline to visit 2 (7 -10 days))
- Pre-Sleep Arousal Scale(Baseline)
- Insomnia Severity Index(Baseline)
- Epworth Sleepiness Scale(Baseline)
- Berlin Questionnaire(Baseline)
研究者
Peter Colvonen
Assistant Clinical Professor
University of California, San Diego