Skip to main content
OpenTrials
Completed

NCT Number: NCT02740517

Usability Evaluation - 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ease of Use

Age range

30 year–95 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • volunteer, no previous exposure to the device

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Percentage of Nights' Data That Were Successfully Recorded

    Time frame: 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 outcomes

  1. Percentage of Recordings With Successful First Time Transmission

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Reassure Respiration Rate Device: Home User Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2016
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.