Non-invasive Blood Pressure Measurement Using Samsung Smartwatch

Not Applicable

Completed

• Conditions: Blood Pressure; Heart Rate
• Interventions: Other: Calm measurement of blood pressure and heart rate (before physical activity); Other: Physical activity; Other: Calm measurement of blood pressure and heart rate (after physical activity)

• Registration Number: NCT05302193
• Lead Sponsor: Czech Technical University in Prague

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-03-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

• any acute illness
• pregnancy
• severe cardiovascular conditions
• severe asthma or other severe respiratory conditions
• diabetes
• hypotension or hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood pressure and heart rate measurement	Calm measurement of blood pressure and heart rate (before physical activity)	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.
Blood pressure and heart rate measurement	Physical activity	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.
Blood pressure and heart rate measurement	Calm measurement of blood pressure and heart rate (after physical activity)	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.

Primary Outcome Measures

Name	Time	Method
Similarity of heart rate measurements from two devices	1 hour	The agreement of heart rate measurements of both monitoring devices will be evaluated.
Similarity of blood pressure measurements from two devices	1 hour	The agreement of systolic and diastolic blood pressure measurements of both monitoring devices will be evaluated.

Trial Locations

Locations (2)

Faculty of Biomedical Engineering, Czech Technical University in Prague; 🇨🇿 Kladno, Czechia

Faculty of Biomedical Engineering, Czech Technical University in Prague; 🇨🇿 Kladno, Czechia