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

Planexta, Inc59 enrolled

Overview

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).

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

HRV

Interventions

SenceBandDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Doctor Sam Medical Network

Kyiv, Kyiv Oblast, Ukraine

Outcomes

Primary Outcomes

RR interval accuracy

Accuracy of RR intervals estimating

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

Secondary Outcomes

RR-intervals passing

Frequency of passing of determination of RR-intervals

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

HRV accuracy for time-domain measures

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

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

HRV accuracy for frequency-domain measures

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

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

HRV accuracy for time-domain measures

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

Time frame: 24 hours intervals

HRV accuracy for frequency-domain measures

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

Time frame: 24 hours intervals

Data from ClinicalTrials.gov

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