Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch

Study Overview
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Brief Summary
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The aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch

Detailed Description
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Blood pressure is one of the basic vital signs monitored and is one of the most important indicators of a patient's health status. Cardiovascular disease is one of the leading causes of death worldwide. One of the major risk factors for cardiovascular disease is hypertension, which is globally attributed to one third of deaths in the world population. To improve the prevention of hypertension, self-monitoring of blood pressure is increasingly recommended. This project involves an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch compared to a medical grade digital tonometer with a cuff placed on the arm.

Official Title
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Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch

Conditions
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Hypertension, Blood Pressure

Intervention / Treatment
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* Other: Long-term non-invasive Blood pressure monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer Exclusion Criteria: post-traumatic conditions of the upper limbs tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands cardiac arrhythmias circulatory or peripheral varcular disease aortic valve disease myocardiopathy other cardiovascular diseases pregnancy kidney disease diabetes neurotic disorder haemostatic disorders use of blood-thinning drugs

Ages Eligible for Study
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Minimum Age: 22 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: Interventional prospective single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch<br>Measurement of a non-invasive Blood pressure and Heart rate using a reference medical grade digital tonometer Omron and a smartwatch Samsung Galaxy Watch during 20-40 days every morning and evening. | Other: Long-term non-invasive Blood pressure monitoring<br>* All measurements during the experiment include only non-invasive Blood pressure and Heart rate measurements. Measurements will be taken using a smartwatch attached to the wrist and a digital tonometer with a cuff placed on the other arm. Paired readings will be compared.<br>* Other names: Long-term non-invasive Heart rate monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure agreement between smartwatch and digital tonometer | The agreement of Blood pressure measurements between smartwatch and medical grade reference digital tonometer | 20-40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate agreement between smartwatch and digital tonometer | The agreement of Heart rate measurements between smartwatch and medical grade reference digital tonometer | 20-40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartwatch, Blood pressure, Heart rate