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

Not Applicable

• Conditions: Hypertension; Blood Pressure
• Interventions: Other: Long-term non-invasive Blood pressure monitoring

• Registration Number: NCT06098092
• Lead Sponsor: Czech Technical University in Prague

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-09
• Study Start: 2023-10-13
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Primary Completion: 2024-03-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch	Long-term non-invasive Blood pressure monitoring	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.

Primary Outcome Measures

Name	Time	Method
Blood pressure agreement between smartwatch and digital tonometer	20-40 days	The agreement of Blood pressure measurements between smartwatch and medical grade reference digital tonometer

Secondary Outcome Measures

Name	Time	Method
Heart rate agreement between smartwatch and digital tonometer	20-40 days	The agreement of Heart rate measurements between smartwatch and medical grade reference digital tonometer

Trial Locations

Locations (1)

Czech Technical University in Prague; 🇨🇿 Kladno, Czechia