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Completed

NCT Number: NCT06098092

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

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

Completed

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Key information

Conditions

Hypertension Blood Pressure Cardiovascular Diseases Vascular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Czech Technical University in Prague, Kladno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long-term non-invasive Blood pressure monitoring

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.

Other names: Long-term non-invasive Heart rate monitoring

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Official study title

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

Acronym: BPLONG

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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