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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HRV
- Sponsor
- Planexta, Inc
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- RR interval accuracy
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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).
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
RR interval accuracy
Time Frame: 5-minute intervals every 30 minutes within 24 hours
Accuracy of RR intervals estimating
Secondary Outcomes
- 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)