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

NCT06098092 | Completed

• 1 other identifier: NVT_02_2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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

Conditions

Hypertension; Blood Pressure

Keywords

Smartwatch; Blood pressure; Heart rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart rate agreement between smartwatch and digital tonometer

  20-40 days

Study Arms (1)

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.

Other: Long-term non-invasive Blood pressure monitoring

Interventions

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.

Also known as: Long-term non-invasive Heart rate monitoring

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteer

You may not qualify if:

• 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

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (2)

Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Faculty of biomedical Engineering, Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related Publications (1)

• Walzel S, Sebestova H, Rafl-Huttova V, Rozanek M, Rafl J. Long-term accuracy and stability of blood pressure measurements from a smartwatch: Prospective validation study. Digit Health. 2026 Jan 22;12:20552076261415923. doi: 10.1177/20552076261415923. eCollection 2026 Jan-Dec.

  PMID: 41602947 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jakub Rafl

  Czech Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional prospective single-arm study

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 24, 2023
• Study Start: October 13, 2023
• Primary Completion: October 30, 2025
• Study Completion: November 1, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Unlimited from the time of processing complete measured data
• Access Criteria: Publicly available to everyone

Locations

CZ (2)