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Clinical Trials/NCT06098092
NCT06098092CompletedNot Applicable

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

Czech Technical University in Prague2 sites in 1 country42 target enrollmentStarted: October 13, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
2
Primary Endpoint
Blood pressure agreement between smartwatch and digital tonometer

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • neurotic disorder
  • haemostatic disorders
  • use of blood-thinning drugs

Arms & Interventions

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

Experimental

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.

Intervention: Long-term non-invasive Blood pressure monitoring (Other)

Outcomes

Primary Outcomes

Blood pressure agreement between smartwatch and digital tonometer

Time Frame: 20-40 days

The agreement of Blood pressure measurements between smartwatch and medical grade reference digital tonometer

Secondary Outcomes

  • Heart rate agreement between smartwatch and digital tonometer(20-40 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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