Usability Evaluation - Reassure Respiration Rate Device: Home User Study

Completed

• Conditions: Ease of Use

• Registration Number: NCT02740517
• Lead Sponsor: ResMed

Brief Summary

This is a usability evaluation of the Reassure device. The device is a non-contact device which passively monitors breathing.

The purpose of this usability evaluation is to understand any issues that the intended user population have while using the device unsupervised in the home and to determine if the device can collect data that is of sufficient quality to be successfully analysed for respiration rate.

Detailed Description

The aim of the set of Reassure Home User Trials is to understand any usability issues that users have while using the Reassure non contact monitor in their home environment.

Other objectives:

* To gather useful feedback on the user interface and suggestions for its improvement.

* To gather information on the device stability in the more variable conditions of the home user environment.

* To gather data in order to demonstrate compliance with IEC62366, and thus IEC60601-1

The users had the device for a minimum of 10 nights, to confirm if the device could be used for an extended period and the likely compliance rates of users

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-11
• Study Completion: 2015-12
• 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: 2021-04
• Results First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Results First Posted: 2021-05-07
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• volunteer, no previous exposure to the device

Exclusion Criteria

• restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Nights' Data That Were Successfully Recorded	At least 10 nights	The definitions utilised to determine the patient's success or otherwise at making a recording of their sleep respiration data are: • That 67% of the duration of the recording has to be of sufficient quality for the respiration rate algorithms to be able to discern a respiration rate.; AND; • The duration of analysable data is to be at least 2 hours.

Secondary Outcome Measures

Name	Time	Method
Percentage of Recordings With Successful First Time Transmission	For at least 10 nights of recordings	Percentage of the recordings that were successfully transmitted from the home location to the central database on the day of the recording