NCT02740517

Usability Evaluation - Reassure Respiration Rate Device: Home User Study

Reassure Respiration Rate Device: Home User Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 30 Years – 95 Years
• Healthy volunteers: Accepted

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

Conditions

• Ease of Use

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2016-04-15
• Last updated: 2021-05-07
• Results posted: 2021-05-07