Reliability of Measuring Blood Pressure With a Smartwatch

Czech Technical University in Prague

Status: Enrolling

Conditions: Heart Rate; Blood Pressure

Treatments: Other: Resting measurement of blood pressure and heart rate

Study type: Interventional

Funder types: Other

Identifiers

NCT05401435

NIBPsmartwatch22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Blood pressure and heart rate measurement

Experimental group

Description:

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.

Treatment:

Other: Resting measurement of blood pressure and heart rate