Respiratory Rate MonitoringBREATHWATCHNCT07578389
Validation of Respiratory Rate Measurement Accuracy Using a Smartwatch
A study testing Respiratory rate monitoring using wearable device in people with Respiratory Rate Monitoring, run by Czech Technical University in Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Rate Monitoring
- What is being tested?
- Respiratory rate monitoring using wearable device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 13 Dec 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Respiratory Rate Monitoring
- Being tested
- Respiratory rate monitoring using wearable device
- Keywords
- Respiratory rate, Wearable devices, Respiratory monitoring, Physiological monitoring, Wearable sensors, Non-invasive monitoring, Validation study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory rate monitoring using wearable deviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Respiratory rate monitoring using wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the experimental measurement session (approximately 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start13 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Rate MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional prospective single-arm study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Walzel, PhD, Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578389
- Sponsor's protocol ID
- NVT_01_2026
- Acronym
- BREATHWATCH
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Respiratory Rate Measurement Accuracy Using a Smartwatch
- ClinicalTrials.gov ID
- NCT07578389
- Acronym / sponsor ID
- BREATHWATCH / NVT_01_2026
- Conditions
- Respiratory Rate Monitoring
- Keywords
- Respiratory rate, Wearable devices, Respiratory monitoring, Physiological monitoring, Wearable sensors, Non-invasive monitoring, Validation study
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 13 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional prospective single-arm study
| Arm | Type | Receives |
|---|---|---|
| Respiratory rate monitoring with wearable device and reference monitoring systems | Experimental | Other: Respiratory rate monitoring using wearable deviceMeasurement of respiratory rate using a wearable device and reference monitoring systems in healthy adult volunteers during a short experimental protocol under different breathing conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory rate monitoring using wearable deviceRespiratory 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. | Other | Respiratory rate monitoring with wearable device and reference monitoring systems |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes. The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Walzel, PhD principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory rate monitoring using wearable device in people with Respiratory Rate Monitoring, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of respiratory rate measurement using a wearable device (time frame: During the experimental measurement session (approximately 20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.