Reliability of Measuring Blood Pressure With a Smartwatch

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reliability of Measuring Blood Pressure With a Smartwatch

Conditions
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Blood Pressure, Heart Rate

Intervention / Treatment
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* Other: Resting measurement of blood pressure and heart rate


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Two measuring devices are active simultaneously during single measurement of blood pressure and heart rate on each participant. Measurements are repeated 2 times a day for 28 days. The functioning of two measuring devices is compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood pressure and heart rate measurement<br>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. | Other: Resting measurement of blood pressure and heart rate<br>* Simultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations | 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. | 28 days | 
| Change in long-term similarity of heart rate measurements from two devices | 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. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pressure measurement, heart rate measurement, smartwatch