Long-term Accuracy and Stability of Blood Pressure Measurements From a Smartwatch: Prospective Validation Study (BPLONG)

March 10, 2026 updated by: Czech Technical University in Prague

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Kladno, Czechia, 27201
        • Czech Technical University in Prague
      • Kladno, Czechia, 27201
        • Faculty of biomedical Engineering, Czech Technical University in Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20-40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate agreement between smartwatch and digital tonometer
Time Frame: 20-40 days
The agreement of Heart rate measurements between smartwatch and medical grade reference digital tonometer
20-40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Technical University in Prague

Investigators

  • Principal Investigator: Jakub Rafl, Czech Technical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2023

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVT_02_2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/

IPD Sharing Time Frame

Unlimited from the time of processing complete measured data

IPD Sharing Access Criteria

Publicly available to everyone

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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