Fitbit Sleep Apnea Alert Software Validation Study
试验速览
- 阶段
- 不适用
- 发起方
- Fitbit LLC
- 入组人数
- 303
- 试验地点
- 6
- 主要终点
- Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device.
研究概览
简要总结
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. The Sleep Apnea Alert software analyses data from a Fitbit commercially available wrist photoplethysmogram (PPG) device. The Sleep Apnea Alert software is an investigational software as medical device (SaMD) and is designed to retrospectively process data and flag users who have physiological signals consistent with an apnea-hypopnea index (AHI) of 15 or greater. This clinical validation study will be used to validate Fitbit's PPG-based sleep apnea algorithm. The outputs of the Fitbit Sleep Apnea Alert software will not be available to study participants, as the scope of this study is to gather validation data only and does not include testing product usability components.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Capable of giving informed consent
- •Comfortable reading the provided written study instructions in English (and/or local language) and using a smartphone in English (and/or local language).
- •Have medical insurance either in the form of private insurance or a national health program.
排除标准
- •No implanted cardiac devices
- •Not pregnant. Pregnancy status will be confirmed per patient report of medical history, i.e., patients will be asked if they are pregnant or may be pregnant, and date of last menstrual cycle.
- •No medical conditions which might lead to consistently low levels of perfusion in the vasculature at the wrist
结局指标
主要结局
Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device.
时间窗: Nightly basis averaged over 7 nights.
Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or \<15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate (averaged over 7 nights) from the wearable device. \[This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI\<15 respectively\]
次要结局
- Single night comparison between PSG and wearable device data on a per-subject basis(1 night)
- Single night comparison between PSG and wearable device data on a per-epoch basis(1 night)