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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06911541
Enrollment
29
Registered
2025-04-04
Start date
2025-05-16
Completion date
2025-08-10
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Respiratory rate, wireless monitoring, accelerometer

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.

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.

Sponsors

Haraldsplass Deaconess Hospital
CollaboratorOTHER
Eupnea AS
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Validation of correctness of the sensorone hourThe 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026