Trial Outcomes & Findings for Usability Evaluation - Reassure Respiration Rate Device: Home User Study (NCT NCT02740517)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

48 participants

Primary outcome timeframe

At least 10 nights

Results posted on

2021-05-07

Participant Flow

Devices used in the subjects' own homes to monitor their respiration rates whilst asleep in their own beds. Subjects all naïve to the device. A mix of couples and single subjects used. The subjects are predominately senior citizens to replicate the most likely user of the device

Participant milestones

Participant milestones
Measure	Home User Trial Phase 1 (HUT1) First phase of the home user trial.	Home User Trial Phase 2 (HUT2) Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1.	Home User Trial Phase 3 (HUT3) Third phase of home user trial, testing the final improvements to the device.
Overall Study STARTED	19	11	18
Overall Study COMPLETED	19	11	18
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Usability Evaluation - Reassure Respiration Rate Device: Home User Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home User Trial Phase 1 (HUT1) n=19 Participants First phase of the home user trial.	Home User Trial Phase 2 (HUT2) n=11 Participants Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1.	Home User Trial Phase 3 (HUT3) n=18 Participants Third phase of home user trial, testing the final improvements to the device.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants	19 Participants n=4 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	29 Participants n=4 Participants
Sex/Gender, Customized	19 participants n=5 Participants	11 participants n=7 Participants	18 participants n=5 Participants	48 participants n=4 Participants
Region of Enrollment Ireland	19 participants n=5 Participants	11 participants n=7 Participants	18 participants n=5 Participants	48 participants n=4 Participants
Part of a Couple	11 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants	38 Participants n=4 Participants
Single	7 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Home User Trial Phase 1 (HUT1) n=19 Participants First phase of the home user trial.	Home User Trial Phase 2 (HUT2) n=11 Participants Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1.	Home User Trial Phase 3 (HUT3) n=18 Participants Third phase of home user trial, testing the final improvements to the device.
Percentage of Nights' Data That Were Successfully Recorded	79 percentage of nights' data	86 percentage of nights' data	100 percentage of nights' data

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Home User Trial Phase 1 (HUT1) n=19 Participants First phase of the home user trial.	Home User Trial Phase 2 (HUT2) n=11 Participants Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1.	Home User Trial Phase 3 (HUT3) n=18 Participants Third phase of home user trial, testing the final improvements to the device.
Percentage of Recordings With Successful First Time Transmission	49 percentage of first time transmissions	76.7 percentage of first time transmissions	96.7 percentage of first time transmissions

Adverse Events

Home User Trial Phase 1 (HUT1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Home User Trial Phase 2 (HUT2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Home User Trial Phase 3 (HUT3)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Phillips

ResMed

Phone: +44 7789633508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place