Usability Evaluation - Reassure Respiration Rate Device: Home User Study

Reassure Respiration Rate Device: Home User Study

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.

Study Overview

• Status: Completed
• Conditions: Ease of Use

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 Type: Observational
• Enrollment (Actual): 48

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 60 volunteers, all naïve to the device. The majority of the volunteers to be >65 years old, to represent the likely user profile: person with a set of chronic diseases, and not necessarily technically adept

Description

Inclusion Criteria:

• volunteer, no previous exposure to the device

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
HUT1; First phase of the home user trial. 19 users, 12 who were part of a couple and 7 who were single.
HUT2; Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1. Total 11 users. Main change to device was a simpler set of displays and button-sequence on a 24 hour period.
HUT3; Third phase of home user trial, testing the final improvements to the device. A total of 18 users, 16 of which who were part of a couple and 2 who were single. Main change was the introduction of a scheduled recording option, making the device totally automatic in routine use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Nights' Data That Were Successfully Recorded	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.	At least 10 nights

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 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): May 7, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: D22105-115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Trial to validate the user features of the new medical device. Trial registered with ClinicalTrials.gov only because it involves human volunteers. No plans to publish