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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2020-01-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validity and Reliability of Optical Heart Rate Sensors

NCT05525000

Health Care Utilization

COMPLETED NA

Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Remote Photoplethysmography

NCT06829615

Heart Rate Heart Rate Variability Breathing Rate +1 more

COMPLETED NA

Validation of a Sensor for Non-Invasive Measurements

NCT03463148

CHF Renal Disease Hypertension

COMPLETED

Validation of a Vital Signs Monitoring Wristband

NCT05566886

Coronary Artery Disease

COMPLETED

The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III

NCT02973243

Cardiac Arrest Renal Failure Respiration Failure +2 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HRV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

SenceBand

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes