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

NCT06911541 | Completed

• 1 other identifier: Eupnea-2025-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Respiratory rate; wireless monitoring; accelerometer

Outcome Measures

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.

  one hour

Study Arms (1)

Adult hospitalized patients

EXPERIMENTAL

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

Device: Wireless respiratory rate monitor

Interventions

Wireless respiratory rate monitor DEVICE

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.

Adult hospitalized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eupnea AS: lead
• Haraldsplass Deaconess Hospital: collaborator

Study Sites (1)

Haraldsplass Deaconess Hospital

Bergen, 5021, Norway

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: April 4, 2025
• Study Start: May 16, 2025
• Primary Completion: June 15, 2025
• Study Completion: August 10, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-06

Locations

NO (1)