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NCT06098092 Clinical Trial

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

Hypertension Clinical Trial

— BPLONG  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06098092
Other study ID # NVT_02_2023
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 13, 2023
Est. completion date October 15, 2024

Study information
Verified date October 2023
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date October 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
Czechia Czech Technical University in Prague Kladno

Sponsors (1)
Lead Sponsor Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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