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

August 12, 2025 updated by: Eupnea AS
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haraldsplass Deaconess Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eupnea AS

Collaborators

Haraldsplass Deaconess Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2025

Primary Completion (Actual)

June 15, 2025

Study Completion (Actual)

August 10, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Eupnea-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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