NCT02740478

Reassure Device: Measurement Accuracy of Continuous Respiration Rate

A Comparison of the Non-contact Reassure Device Measurement Accuracy of Respiration Rate With SOMNOScreen, When Measured on a Continuous Basis Whilst the Subjects Are Asleep

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Accuracy of Respiration Rate Measurement

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2016-04-15
• Last updated: 2021-04-02
• Results posted: 2021-04-02