Reliability of Measuring Blood Pressure With a Smartwatch

Not Applicable

• Conditions: Heart Rate; Blood Pressure
• Interventions: Other: Resting measurement of blood pressure and heart rate

• Registration Number: NCT05401435
• Lead Sponsor: Czech Technical University in Prague

Brief Summary

The aim of this study is to verify the long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters.

Detailed Description

Recently, smartwatches can measure a wide range of biological signals, including heart rate and blood pressure. The short-term reliability of blood pressure measurements after the required calibration has been studied, but long-term reliability is still a question. The aim of the project is to experimentally evaluate the reliability of long-term blood pressure measurement with a Samsung smart watch between two consecutive calibrations over a period of 28 days in comparison with a digital tonometer (Omron) approved as a medical device. Volunteers will measure blood pressure and heart rate manually twice a day from a smartwatch and a digital tonometer simultaneously. The agreement of the measurements of both devices will be evaluated.

Study Timeline

• Study Start: 2022-05-04
• Study First Submitted: 2022-05-23
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-01
• Last Update Submitted: 2022-06-01
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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	Resting measurement of blood pressure and heart rate	Resting blood pressure and heart rate measurement regularly one value in the morning and evening for 28 days. The volunteer measures the parameters simultaneously on both devices (smartwatch and digital tonometer). In total, each participant will undergo this measurement 56 times.

Primary Outcome Measures

Name	Time	Method
Change in long-term similarity of heart rate measurements from two devices	28 days	The long-term agreement of heart rate measurements of both monitoring devices will be evaluated. This means that we evaluate the changes in the similarity of measured heart rates over a period of 28 days.
Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations	28 days	The long-term agreement of systolic and diastolic blood pressure measurements of both monitoring devices between two consecutive smartwatch calibrations will be evaluated. This means that we evaluate the changes in the similarity of measured blood pressures over a period of 28 days.

Trial Locations

Locations (1)

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