Reassure Device: Measurement Accuracy of Continuous Respiration Rate

Completed

• Conditions: Accuracy of Respiration Rate Measurement

• Registration Number: NCT02740478
• Lead Sponsor: ResMed

Brief Summary

The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects over a number of hours when the subjects are lying still or in bed asleep

Detailed Description

Each recording comprised at least 2 hours duration. The subject was lying on a bed, wearing the SomnoScreen and with the Reassure on a bed-side table in the recommended position: at arm's length, pointing at the subject's upper torso.

The subject was asked to lie in set positions on the bed for 20 minutes at a time. The data was recorded continuously for the duration of the trial and so encompassed the acts of turning from one position to another and any minor movement made by the subject. If the subject fell asleep during the trial, they were only woken when it came time for the next position change.

Key Duration Remarks Supine \>=20minutes Subject Lying on back Prone \>=20minutes Subject Lying face down Facing Left \>=20minutes Subject's Chest facing Reassure device Facing Right \>=20minutes Subject's Back facing Reassure device Foetal Left \>=20minutes Subject's Chest facing Reassure device Foetal Right \>=20minutes Subject's Back facing Reassure device

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Results First Submitted: 2016-04-25
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Results First Posted: 2021-04-02
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Willing Volunteer

Exclusion Criteria

• Restless leg syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiration Rate Comparability	2 hour recording	The respiration rate measured contemporaneously by the Reassure and the reference device, SomnoScreen, are compared on a second-by-second basis, over the whole recording duration. The difference between the two respiration rate measurements (the delta) for all 20 subjects' recordings are plotted on a normal distribution chart, giving 130,000 data points. The distribution chart reveals the mean difference between the two devices' measurements and the Standard Deviation (SD). The measure of success is if the 95% (ie 2SD) of the difference in the respiration rate indicated by the two devices (the delta) is less than 5 breaths per minute. This measure is derived from the peer review paper by Lim et al, cited in the References section