Usability Evaluation - Reassure Respiration Rate Device: Home User Study

ResMed

Status: Completed

Conditions: Ease of Use

Study type: Observational

Funder types: Industry

Identifiers

NCT02740517

D22105-115

Details and patient eligibility

About

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.

Full 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

Enrollment: 48 patients

Sex: All

Ages: 30 to 95 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• volunteer, no previous exposure to the device

Exclusion criteria

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

Trial design

48 participants in 3 patient groups

HUT1

Description:

First phase of the home user trial. 19 users, 12 who were part of a couple and 7 who were single.

HUT2

Description:

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

Description:

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.