Validation of Respiratory Rate Measurement Accuracy Using a Smartwatch (BREATHWATCH)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Respiratory Rate Monitoring
• Intervention / Treatment: Other: Respiratory rate monitoring using wearable device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Kladno, Czechia, 272 01
    • Czech Technical University in Prague

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respiratory rate monitoring with wearable device and reference monitoring systems; Measurement of respiratory rate using a wearable device and reference monitoring systems in healthy adult volunteers during a short experimental protocol under different breathing conditions.	Other: Respiratory rate monitoring using wearable device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of respiratory rate measurement using a wearable device	Agreement between respiratory rate measured by the wearable device and reference measurements obtained from spirometry and a clinical vital signs monitor in healthy volunteers.	During the experimental measurement session (approximately 20 minutes)

Collaborators and Investigators

• Sponsor: Czech Technical University in Prague
• Investigators: Principal Investigator: Simon Walzel, PhD, Czech Technical University in Prague

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Wearable sensors; Validation study; Wearable devices; Respiratory rate; Non-invasive monitoring; Respiratory monitoring; Physiological monitoring
• Other Study ID Numbers: NVT_01_2026

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 Access Criteria: Unlimited from the time of processing complete measured data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No