Verily Clinical Study Watch Analytical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Accuracy of pulse rate when wearer is at rest
研究概览
简要总结
This study is designed to evaluate the performance of the Verily Clinical Study Watch for the quantification of participants' movement and pulse rate when the wearer is at rest.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is ≥ 22 and ≤ 80 years old
- •Participant understands the study requirements and is able and willing to provide written informed consent
- •Participant is without significant limitation in ability to participate in the study, in the opinion of the investigator
- •Participant owns a smartphone with a data plan and be the primary user of the smartphone; smartphone must be compatible with the applications used in the study
- •Participant is a US Resident
排除标准
- •Participant has tremor or significant life-threatening arrhythmia
- •Participant is allergic to nickel or metal jewelry
- •Participant has a known severe allergy to polyester, nylon, or spandex
- •Participant has a known allergic reaction to adhesives or hydrogels
- •Participant has a tattoo covering the area where the watch face would rest on either wrist
- •Participant has planned international travel during the study
结局指标
主要结局
Accuracy of pulse rate when wearer is at rest
时间窗: Approximately 14-day at-home observational period with two virtual visits, one at the beginning and the other at the end of the at-home period.
To evaluate the accuracy of the Verily Clinical Study Watch's ability to measure pulse rate when wearer is at rest during unsupervised free-living conditions. Pulse rate measurements will be compared against heart rate output from the reference device (FDA cleared ECG patch).
Sensitivity of movement detection
时间窗: Approximately 14-day at-home observational period with two virtual visits, one at the beginning and the other at the end of the at-home period.
To evaluate the accuracy of the Verily Clinical Study Watch's ability to detect movement (rest vs not rest) during supervised conditions. Movement detection will be compared against virtual supervised observer-reference labels of rest vs not rest.
Specificity of movement detection
时间窗: Approximately 14-day at-home observational period with two virtual visits, one at the beginning and the other at the end of the at-home period.
To evaluate the accuracy of the Verily Clinical Study Watch's ability to detect movement (rest vs not rest) during supervised conditions. Movement detection will be compared against virtual supervised observer-reference labels of rest vs not rest.
次要结局
未报告次要终点