Respiratory Rate Accuracy TestNCT06911541
Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor
A study testing Wireless respiratory rate monitor in people with Respiratory Rate Accuracy Test and Capnography, run by Eupnea AS at 1 site in Norway.
Trial summary
Comparing a wireless accelerometer-based sensor that continuously measure breathing rate with the gold standard capnography. The aim is to evaluate if both methods are equivalent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Rate Accuracy Test, Capnography, Wireless Vital Signs Monitoring System
- What is being tested?
- Wireless respiratory rate monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNorway
- Study dates
- 16 May 2025to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the Hospital
- Expected to remain undisturbed for at least one hour
Who cannot join
- Not able to give informed consent
- Use of high flow oxygen therapy
- Skin disease preventing proper attachment of the sensor
- Implanted electronic medical device.
- Known infection or colonisation with microbes necessitating protective measures above routine care
Trial locations and contacts
1 site in 1 country.
About this study
Comparing a wireless accelerometer-based sensor that continuously measure breathing rate with the gold standard capnography. The aim is to evaluate if both methods are equivalent.
- Conditions
- Respiratory Rate Accuracy Test, Capnography, Wireless Vital Signs Monitoring System, Respiratory Rate
- Being tested
- Wireless respiratory rate monitor
- Keywords
- Respiratory rate, wireless monitoring, accelerometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless respiratory rate monitorDevice
This sensor is being fasten on the chest of the patients and measures respiratory rate with the help of an accelerometer. Data is being sent wireless to a backend monitor.
| Study group | Role | What they receive |
|---|---|---|
| Adult hospitalized patients | Experimental | Patients are being monitored for one hour with a wireless, accelerometer based respiratory rate sensor and a capnograph. Receives: Device: Wireless respiratory rate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of correctness of the sensor
The respiratory rate measured by the sensor is being compared to the respiratory rate by capnography. A discrepancy of +- 3 breaths/min is within the acceptable range.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start16 May 2025
- Primary completion15 Jun 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Rate Accuracy TestStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eupnea AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Haraldsplass Deaconess Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911541
- Sponsor's protocol ID
- Eupnea-2025-01
- Status last verified
- Jun 2025
- First submitted
- 13 Feb 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steihaug OM, Sjoset TE, Stordal AS, Sleire AD, Odegaard-Olsen O, Tunset A, Jammer I. Clinical validation of a novel accelerometer-based respiratory rate monitor. J Clin Monit Comput. 2026 Jun;40(3):695-702. doi: 10.1007/s10877-026-01419-x. Epub 2026 Feb 7.
PubMed 41649789
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor
- ClinicalTrials.gov ID
- NCT06911541
- Acronym / sponsor ID
- Eupnea-2025-01
- Conditions
- Respiratory Rate Accuracy Test, Capnography, Wireless Vital Signs Monitoring System, Respiratory Rate
- Keywords
- Respiratory rate, wireless monitoring, accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Eupnea ASIndustry (pharma, biotech, devices)
- Collaborators
- Haraldsplass Deaconess Hospital
- Study start
- 16 May 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 4 Apr 2025 (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.
Comparing a wireless accelerometer-based sensor that continuously measure breathing rate with the gold standard capnography. The aim is to evaluate if both methods are equivalent.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult hospitalized patients | Experimental | Device: Wireless respiratory rate monitorPatients are being monitored for one hour with a wireless, accelerometer based respiratory rate sensor and a capnograph. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to the Hospital
- Expected to remain undisturbed for at least one hour
Key exclusion criteria (5 listed)
- Not able to give informed consent
- Use of high flow oxygen therapy
- Skin disease preventing proper attachment of the sensor
- Implanted electronic medical device.
- Known infection or colonisation with microbes necessitating protective measures above routine care
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 |
|---|---|---|
| Wireless respiratory rate monitorThis sensor is being fasten on the chest of the patients and measures respiratory rate with the help of an accelerometer. Data is being sent wireless to a backend monitor. | Device | Adult hospitalized patients |
Primary outcome
Validation of correctness of the sensor
Time frame: one hour
The respiratory rate measured by the sensor is being compared to the respiratory rate by capnography. A discrepancy of +- 3 breaths/min is within the acceptable range.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 41649789Steihaug OM, Sjoset TE, Stordal AS, Sleire AD, Odegaard-Olsen O, Tunset A, Jammer I. Clinical validation of a novel accelerometer-based respiratory rate monitor. J Clin Monit Comput. 2026 Jun;40(3):695-702. doi: 10.1007/s10877-026-01419-x. Epub 2026 Feb 7.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless respiratory rate monitor in people with Respiratory Rate Accuracy Test and Capnography, run by Eupnea AS at 1 site in Norway.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 13 Aug 2025. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Validation of correctness of the sensor (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06911541, which also lists 1 linked publication.
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 13 Aug 2025.