Blood Pressure Sensor of Watch-type Device With ECG Technology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Level of accordance between the ASUS HealthConnect App (Blood Pressure Monitor) and the sphygmomanometer
研究概览
简要总结
The ASUS Blood Pressure App "ASUS HealthConnect" is a software-only mobile medical application. It is designed to be compatible with ASUS VivoWatch SP watches and mobile phones. Used together to create, record, store, and display blood pressure information. This application determines the systolic and diastolic blood pressure and pulse rate and provides numerical and historical graphs after calibration with the cuff-type upper arm blood pressure monitor. The above data is only captured when the user is resting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Level of accordance between the ASUS HealthConnect App (Blood Pressure Monitor) and the sphygmomanometer
时间窗: 1 hour per individual
Excerpted from Regulation 5.2.4.1.2 Data analysis The sphygmomanometer-under-test shall meet the following two criteria. a) Criterion 1 1. The differences of the n individual paired determinations of the sphygmomanometer-under-test and of the observers' readings with the reference sphygmomanometer for all subjects, calculated separately for systolic blood pressure and diastolic blood pressure, shall: i) the mean value of the differences be within or equal to ±5,0 mmHg. ii) the standard deviation no greater than 8,0 mmHg(1,07 kPa). iii) the mean value of the differences and the standard deviation shall be calculated and expressed to at least 0,1 mmHg (0,01 kPa). 2. The reference blood pressure value shall be the average of the observers' readings with the reference sphygmomanometer preceding and following the sphygmomanometerunder-test determination.
次要结局
未报告次要终点