Validation of Respiratory Rate Measurement Accuracy Using a Smartwatch

NCT07578389 | Enrolling By Invitation

• 1 other identifier: NVT_01_2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Rate Monitoring

Keywords

Respiratory rate; Wearable devices; Respiratory monitoring; Physiological monitoring; Wearable sensors; Non-invasive monitoring; Validation study

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Respiratory rate monitoring with wearable device and reference monitoring systems

EXPERIMENTAL

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

Interventions

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.

Respiratory rate monitoring with wearable device and reference monitoring systems

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Czech Technical University in Prague

Kladno, 272 01, Czechia

Location

Study Officials

• Simon Walzel, PhD

  Czech Technical University in Prague

  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: May 5, 2026
• First Posted: May 11, 2026
• Study Start: December 13, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Unlimited from the time of processing complete measured data

Locations

CZ (1)