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

Sponsor
Czech Technical University in Prague (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06098092
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
12.1
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Long-term non-invasive Blood pressure monitoring
 N/A

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
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Interventional prospective single-arm studyInterventional prospective single-arm study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch
Actual Study Start Date :
Oct 13, 2023
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
Oct 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Long-term non-invasive Heart rate monitoring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    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

    • diabetes

    • neurotic disorder

    • haemostatic disorders

    • use of blood-thinning drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Czech Technical University in Prague Kladno Czechia 27201

    Sponsors and Collaborators

    • Czech Technical University in Prague

    Investigators

    • Principal Investigator: Jakub Rafl, Czech Technical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Czech Technical University in Prague
    ClinicalTrials.gov Identifier:
    NCT06098092
    Other Study ID Numbers:
    • NVT_02_2023
    First Posted:
    Oct 24, 2023
    Last Update Posted:
    Oct 24, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Czech Technical University in Prague
    Smartwatch
    Blood pressure
    Heart rate
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Oct 24, 2023