Measuring Accuracy of Wristband for Registration of ECG RR-Intervals for One Hand, SenceBand in Comparison to Holter

HRV Clinical Trial

Official title: 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.

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• HRV

• NCT number: NCT03747861
• Study type: Interventional
• Source: Planexta, Inc
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Completion date: January 24, 2020