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

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

Study Overview

• Status: Completed
• Conditions: Accuracy of Respiration Rate Measurement

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 Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Quantity 20 volunteer subjects willing to undergo the trial: lying still for 2 hours, following a pre-scripted set on lying positions.

Description

Inclusion Criteria:

• Willing Volunteer

Exclusion Criteria:

• Restless leg syndrome

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Volunteers; 20 volunteer subjects, no selection criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiration Rate Comparability	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	2 hour recording

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Paul Phillips, MA, MSc, ResMed Sensor Technologies Ltd

Publications and helpful links

General Publications

• Lim WS, Carty SM, Macfarlane JT, Anthony RE, Christian J, Dakin KS, Dennis PM. Respiratory rate measurement in adults--how reliable is it? Respir Med. 2002 Jan;96(1):31-3. doi: 10.1053/rmed.2001.1203.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: D22105-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Device performance validation, only registered with Clinicaltrials.gov as it entailed human volunteers. No intent to publish