Usability Evaluation - Reassure Respiration Rate Device: Home User Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Reassure Respiration Rate Device: Home User Study

Conditions
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Ease of Use

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: volunteer, no previous exposure to the device Exclusion Criteria: restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HUT1<br>First phase of the home user trial. 19 users, 12 who were part of a couple and 7 who were single. | |
| HUT2<br>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<br>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?
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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 |