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Enrolling by Invitation

NCT Number: NCT07578389

Validation of Respiratory Rate Measurement Accuracy Using a Smartwatch

This prospective study evaluates the accuracy of commercial wearable devices by comparing their respiratory rate measurements against clinical standards like spirometers and ECGs in healthy adults. The goal is to determine if these devices are reliable enough for non-invasive respiratory monitoring in both everyday and medical environments.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Czech Technical University in Prague

Kladno, 272 01, Czechia

About this study

This prospective interventional study evaluates the accuracy of respiratory rate measurement using commercially available wearable devices. Respiratory rate measured by wearable devices will be compared with reference measurements obtained from a spirometer and ECG.

Healthy adult volunteers will participate in a short experimental protocol including different breathing conditions. Respiratory rate will be recorded simultaneously by wearable devices and reference monitoring systems.

The aim of the study is to determine whether wearable devices can reliably measure respiratory rate and to assess their potential for non-invasive respiratory monitoring in everyday and clinical settings.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged 18 years or older
  • Ability to understand the study procedures and provide informed consent
  • Willingness to participate in the experimental measurement protocol

Exclusion criteria

  • Known respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease)
  • Known cardiovascular diseases or conditions limiting safe participation
  • Acute illness or infection at the time of measurement
  • Neurological or musculoskeletal conditions affecting breathing or the ability to participate in the measurement protocol
  • Pregnancy
  • Use of alcohol or other substances affecting physiological measurements at the time of the experiment

Treatment and study plan

Respiratory rate monitoring using wearable device

Other

Respiratory rate monitoring using a wearable device during a controlled experimental protocol in healthy volunteers. Measurements obtained from the wearable device are compared with reference respiratory measurements obtained using spirometry and a clinical vital signs monitor.

Primary outcomes

  1. Accuracy of respiratory rate measurement using a wearable device

    Time frame: During the experimental measurement session (approximately 20 minutes)

    Agreement between respiratory rate measured by the wearable device and reference measurements obtained from spirometry and a clinical vital signs monitor in healthy volunteers.

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Acronym: BREATHWATCH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 11, 2026
Registry last updated
May 11, 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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