An Open Clinical Study of Measuring Accuracy of RR- Intervals and Determining the Heart Rate Variability With a Wristband for Registration of ECG RR Intervals for One Hand, SenceBand Compared to the Holter Monitor.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- RR interval accuracy
研究概览
简要总结
The purpose of the study is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor (LabTech Ltd).
详细描述
Non-randomized, prospective, open clinical trial . The main purpose is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand in real-world condition during 24-hours of routine duties in comparison to a predicate device (Holter monitor). For monitoring HRV each subject will put heart rate monitor SenceBand in the randomly assigned wrist and Holter monitor electrodes will be placed in standard configurations places. Data will be collected during routine duties. SenceBand will collect data from 5-minutes intervals each 30 minutes, Holter will collect data continuously over 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has given written informed consent;
- •Subject is male or female, aged 18-75;
- •Subject has understood and complied with the requirements of the study protocol and;
- •Subject is fluent in Ukrainian.
排除标准
- •Subject has cardiac pacemakers;
- •Subject is a pregnant woman;
- •Subject has an allergy on polyurethane;
- •Subject refers to vulnerable groups of the population;
- •In investigator's opinion subject is not able physically or intellectually to fulfill the requirements of protocol.
结局指标
主要结局
RR interval accuracy
时间窗: 5-minute intervals every 30 minutes within 24 hours
Accuracy of RR intervals estimating
次要结局
- RR-intervals passing(5-minute intervals every 30 minutes within 24 hours of use)
- HRV accuracy for time-domain measures(24 hours intervals)
- HRV accuracy for frequency-domain measures(24 hours intervals)