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

NCT ID: NCT06098092

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-13
• Study Completion Date: 2024-10-15

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.

Conditions

Hypertension; Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch

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.

Group Type: EXPERIMENTAL

Long-term non-invasive Blood pressure monitoring

Intervention Type: OTHER

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.

Interventions

Long-term non-invasive Blood pressure monitoring

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.

Intervention Type: OTHER

Other Intervention Names

Long-term non-invasive Heart rate monitoring

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Czech Technical University in Prague

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jakub Rafl

Role: PRINCIPAL_INVESTIGATOR

Czech Technical University

Locations

Czech Technical University in Prague

Kladno, , Czechia

Countries

Czechia

Other Identifiers

NVT_02_2023

Identifier Type: -

Identifier Source: org_study_id