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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03747861

Enrollment

Registered

2018-11-20

Start date

2019-05-10

Completion date

2020-01-24

Last updated

2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HRV

Keywords

R-R intervals, Heart rate, HRV

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.

Interventions

DEVICESenceBand

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	5-minute intervals every 30 minutes within 24 hours	HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)
HRV accuracy for frequency-domain measures	5-minute intervals every 30 minutes within 24 hours	HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026