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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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HRV

Intervention / Treatment
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* Device: SenceBand


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm for HRV monitoring<br>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<br>* Wristband for registration of ECG RR intervals for one hand, SenceBand will collect data from 5-minutes intervals each 30 minute within 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RR interval accuracy | 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 | 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 | 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 | 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 | HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50) | 24 hours intervals | 
| HRV accuracy for frequency-domain measures | HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF) | 24 hours intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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R-R intervals, Heart rate, HRV