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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747861
• Other study ID #: SenceBand-001
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: January 24, 2020

Study information

• Verified date: February 2020
• Source: Planexta, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• HRV

Intervention

Device:
• SenceBand
Wristband for registration of ECG RR intervals for one hand, SenceBand will collect data from 5-minutes intervals each 30 minute within 24 hours

Locations

Country	Name	City	State
Ukraine	Doctor Sam Medical Network	Kyiv	Kyiv Region

Sponsors (2)

Lead Sponsor	Collaborator
Planexta, Inc	Pharmaxi LLC

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RR interval accuracy	Accuracy of RR intervals estimating	5-minute intervals every 30 minutes within 24 hours
Secondary	RR-intervals passing	Frequency of passing of determination of RR-intervals	5-minute intervals every 30 minutes within 24 hours of use
Secondary	HRV accuracy for time-domain measures	HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)	5-minute intervals every 30 minutes within 24 hours
Secondary	HRV accuracy for frequency-domain measures	HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)	5-minute intervals every 30 minutes within 24 hours
Secondary	HRV accuracy for time-domain measures	HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)	24 hours intervals
Secondary	HRV accuracy for frequency-domain measures	HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)	24 hours intervals