Apollo Remote Observational Sleep Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sleep Onset
研究概览
简要总结
The purpose of this study is to examine how Transcutaneous Vibratory Stimulation (TVS) produced by the Apollo wearable affects sleep and cardiovascular function in a diverse real-world population of Apollo users.
详细描述
The Apollo wearable is a consumer wellness device that offers a non-invasive, non-habit-forming wearable solution to improve performance and recovery under stress in children and adults by delivering gentle wave-like vibrations (Transcutaneous Vibratory Stimulation) to the body.
In this observational cohort study, we will assess sleep and cardiovascular metrics measured during sleep by Oura ring in participants who use Apollo wearable device both historically (2 years in the past) as well as in the future (two years forward). Participants will not be required to make any changes to their activities of daily living or lifestyle except for the continued use of their Apollo wearable devices and answer periodic questionnaires through an online survey tool.
Participant data for days with and without using the Apollo wearable will be analyzed to identify the near term and long term effects of using a TVS device on sleep and cardiovascular signatures. Environmental and confounding data will be derived from the survey data and biometrics data from the wearables.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 or more
- •Use both the Apollo wearable and Oura ring
排除标准
- •Inability to complete questionnaires written in English.
结局指标
主要结局
Sleep Onset
时间窗: Through study completion, an average of 4 years
The amount of time it takes to fall asleep once you are on the bed in seconds
Sleep duration
时间窗: Through study completion, an average of 4 years
Total amount of time spent sleeping in seconds
Deep sleep duration
时间窗: Through study completion, an average of 4 years
Total amount of time spent in deep sleep during sleep sessions in seconds
Average Heart Rate during sleep
时间窗: Through study completion, an average of 4 years
The average heart rate measured during sleep in beats per minute
Lowest Heart Rate during sleep
时间窗: Through study completion, an average of 4 years
The lowest Heart Rate measured during sleep in beats per minutes
Heart Rate Variability during sleep
时间窗: Through study completion, an average of 4 years
The Heart Rate Variability value measured during sleep in milli seconds
Wake time during sleep
时间窗: Through study completion, an average of 4 years
Total amount of time spent awake during a sleep session in seconds
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Through study completion, an average of 4 years
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. With a range of scores 1-21.
Sleep efficiency
时间窗: Through study completion, an average of 4 years
The proportion of time spent sleeping to total time in bed
REM sleep duration
时间窗: Through study completion, an average of 4 years
Total amount of time spent in REM sleep during sleep sessions in seconds
次要结局
- Oura Sleep Score(Through study completion, an average of 4 years)