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

February 14, 2020 updated by: Planexta, Inc

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
    • Kyiv Region
      • Kyiv, Kyiv Region, Ukraine
        • Doctor Sam Medical Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Arm for HRV monitoring
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RR interval accuracy
Time Frame: 5-minute intervals every 30 minutes within 24 hours
Accuracy of RR intervals estimating
5-minute intervals every 30 minutes within 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Planexta, Inc

Collaborators

Pharmaxi LLC

Investigators

  • Principal Investigator: Yulia Kuznetsova-Arabuli, MD, Dr. Sam LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2019

Primary Completion (ACTUAL)

January 24, 2020

Study Completion (ACTUAL)

January 24, 2020

Study Registration Dates

First Submitted

November 17, 2018

First Submitted That Met QC Criteria

November 17, 2018

First Posted (ACTUAL)

November 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SenceBand-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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