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CompletedNCT06911541Updated Aug 13, 2025

Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor

An interventional study of Wireless respiratory rate monitor in Respiratory Rate Accuracy Test, Capnography and Wireless Vital Signs Monitoring System, sponsored by Eupnea AS. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by Eupnea AS · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Rate Accuracy Test
  • Capnography
  • Wireless Vital Signs Monitoring System
  • Respiratory Rate

Keywords

  • Respiratory rate
  • wireless monitoring
  • accelerometer
03

In context

Lead sponsor

This is the only study on the registry with Eupnea AS as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Admitted to the Hospital
  • Expected to remain undisturbed for at least one hour

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Adult hospitalized patients

    Patients are being monitored for one hour with a wireless, accelerometer based respiratory rate sensor and a capnograph.

    Device: Wireless respiratory rate monitor

Interventions

  • DeviceWireless respiratory rate monitor

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one hour

07

Study locations

1 site
  • Haraldsplass Deaconess Hospital
    Bergen, 5021, Norway
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06911541
Lead sponsor
Eupnea AS
Collaborators
Haraldsplass Deaconess Hospital
Responsible party
Sponsor
First posted
Apr 4, 2025
Start date
May 16, 2025
Primary completion
Jun 15, 2025
Completion
Aug 10, 2025
Last update
Aug 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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