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

NCT ID: NCT06911541

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2025-08-10

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adult hospitalized patients

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

Group Type EXPERIMENTAL

Wireless respiratory rate monitor

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haraldsplass Deaconess Hospital

OTHER

Sponsor Role collaborator

Eupnea AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Haraldsplass Deaconess Hospital

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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Eupnea-2025-01

Identifier Type: -

Identifier Source: org_study_id

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