Non-invasive Blood Pressure Measurement Using Samsung Smartwatch

NCT ID: NCT05302193

Last Updated: 2025-03-25

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-09-30

Brief Summary

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The aim of this study is to verify the accuracy of blood pressure and heart rate measurement by Samsung smartwatches compared to a standard monitor of vital signs used in intensive care units.

Detailed Description

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Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. Heart rate measurement is a common function of smartwatches, some smartwatch models even measure blood pressure. The study aims to compare the measurement of blood pressure and heart rate using the latest smartwatch with a vital signs monitor used in clinical practice. Blood pressure and heart rate measurements will be taken by hand from the watch and the vital signs monitor simultaneously. The agreement of the measurements of both devices will be evaluated.

Conditions

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Blood Pressure Heart Rate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Two measuring devices are active simultaneously during measurement of blood pressure and heart rate on each participant and their functioning is compared.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Blood pressure and heart rate measurement

Calm measurement of blood pressure and heart rate simultaneously by smartwatch and vital signs monitor. Each participant will undergo this measurement a total of 6 times.

Group Type EXPERIMENTAL

Calm measurement of blood pressure and heart rate (before physical activity)

Intervention Type OTHER

Simultaneous blood pressure and heart rate measurements at minutes 2 and 5.5 of the experiment.

Physical activity

Intervention Type OTHER

Five minutes of physical activity, between times 7.5 min and 12.5 min of the experimental part. Riding on a spinning ergometer with a standardized load of 1 W/kg.

Calm measurement of blood pressure and heart rate (after physical activity)

Intervention Type OTHER

Simultaneous blood pressure and heart rate measurements at times 15.5, 17, 20.5 and 22 minutes of the experimental part.

Interventions

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Calm measurement of blood pressure and heart rate (before physical activity)

Simultaneous blood pressure and heart rate measurements at minutes 2 and 5.5 of the experiment.

Intervention Type OTHER

Physical activity

Five minutes of physical activity, between times 7.5 min and 12.5 min of the experimental part. Riding on a spinning ergometer with a standardized load of 1 W/kg.

Intervention Type OTHER

Calm measurement of blood pressure and heart rate (after physical activity)

Simultaneous blood pressure and heart rate measurements at times 15.5, 17, 20.5 and 22 minutes of the experimental part.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers

Exclusion Criteria

* any acute illness
* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* diabetes
* hypotension or hypertension
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Czech Technical University in Prague

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronika Rafl Huttova, MSc

Role: PRINCIPAL_INVESTIGATOR

Czech Technical University in Prague

Jakub Rafl, PhD

Role: PRINCIPAL_INVESTIGATOR

Czech Technical University in Prague

Martin Rozanek, PhD

Role: PRINCIPAL_INVESTIGATOR

Czech Technical University in Prague

Locations

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Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, , Czechia

Site Status

Countries

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Czechia

References

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Hahnen C, Freeman CG, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI, van Helmond N. Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e16811. doi: 10.2196/16811.

Reference Type BACKGROUND
PMID: 32049066 (View on PubMed)

Other Identifiers

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NIBPsmartwatch21

Identifier Type: -

Identifier Source: org_study_id

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