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Completed

NCT Number: NCT03747861

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

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).

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Key information

Conditions

HRV

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doctor Sam Medical Network

Kyiv, Kyiv Oblast, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SenceBand

Device

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

Primary outcomes

  1. RR interval accuracy

    Time frame: 5-minute intervals every 30 minutes within 24 hours

    Accuracy of RR intervals estimating

Secondary outcomes

  1. RR-intervals passing

    Time frame: 5-minute intervals every 30 minutes within 24 hours of use

    Frequency of passing of determination of RR-intervals

  2. 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)

  3. 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)

  4. HRV accuracy for time-domain measures

    Time frame: 24 hours intervals

    HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)

  5. HRV accuracy for frequency-domain measures

    Time frame: 24 hours intervals

    HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)

Sponsors and collaborators

Lead sponsor

Planexta, Inc

Industry

Collaborators

  • Pharmaxi LLC

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2018
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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