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

Not Applicable

Completed

• Conditions: HRV
• Interventions: Device: SenceBand

• Registration Number: NCT03747861
• Lead Sponsor: Planexta, Inc

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.

Study Timeline

• Study First Submitted: 2018-11-17
• Study First Submitted QC: 2018-11-17
• Study First Posted: 2018-11-20
• Study Start: 2019-05-10
• Primary Completion: 2020-01-24
• Study Completion: 2020-01-24
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Subject has given written informed consent;
2. Subject is male or female, aged 18-75;
3. Subject has understood and complied with the requirements of the study protocol and;
4. Subject is fluent in Ukrainian.

Exclusion Criteria

1. Subject has cardiac pacemakers;
2. Subject is a pregnant woman;
3. Subject has an allergy on polyurethane;
4. Subject refers to vulnerable groups of the population;
5. In investigator's opinion subject is not able physically or intellectually to fulfill the requirements of protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm for HRV monitoring	SenceBand	For monitoring HRV each subject will put Wristband for registration of ECG RR intervals for one hand, SenceBand in the left wrist and Holter monitor electrodes will be placed in standard configurations places.

Primary Outcome Measures

Name	Time	Method
RR interval accuracy	5-minute intervals every 30 minutes within 24 hours	Accuracy of RR intervals estimating

Secondary Outcome Measures

Name	Time	Method
RR-intervals passing	5-minute intervals every 30 minutes within 24 hours of use	Frequency of passing of determination of RR-intervals
HRV accuracy for time-domain measures	24 hours intervals	HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)
HRV accuracy for frequency-domain measures	24 hours intervals	HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)

Trial Locations

Locations (1)

Doctor Sam Medical Network; 🇺🇦 Kyiv, Kyiv Region, Ukraine