Ease of Use
Conditions
Brief 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
Interventions
None listed
Sponsors
ResMed
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* volunteer, no previous exposure to the device
Exclusion criteria
* restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Nights' Data That Were Successfully Recorded | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Recordings With Successful First Time Transmission | 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 |
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Home User Trial Phase 1 (HUT1) First phase of the home user trial. | 19 |
| 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. | 11 |
| Home User Trial Phase 3 (HUT3) Third phase of home user trial, testing the final improvements to the device. | 18 |
| Total | 48 |
Baseline characteristics
| Characteristic | Home User Trial Phase 2 (HUT2) | Home User Trial Phase 3 (HUT3) | Home User Trial Phase 1 (HUT1) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 3 Participants | 15 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 15 Participants | 4 Participants | 19 Participants |
| Part of a Couple | 11 Participants | 16 Participants | 11 Participants | 38 Participants |
| Region of Enrollment Ireland | 11 participants | 18 participants | 19 participants | 48 participants |
| Sex/Gender, Customized | 11 participants | 18 participants | 19 participants | 48 participants |
| Single | 0 Participants | 2 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 11 | 0 / 18 |
| other Total, other adverse events | 0 / 19 | 0 / 11 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 11 | 0 / 18 |
Outcome results
Primary
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.
Time frame: At least 10 nights
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home User Trial Phase 1 (HUT1) | Percentage of Nights' Data That Were Successfully Recorded | 79 percentage of nights' data |
| Home User Trial Phase 2 (HUT2) | Percentage of Nights' Data That Were Successfully Recorded | 86 percentage of nights' data |
| Home User Trial Phase 3 (HUT3) | Percentage of Nights' Data That Were Successfully Recorded | 100 percentage of nights' data |
Secondary
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
Time frame: For at least 10 nights of recordings
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home User Trial Phase 1 (HUT1) | Percentage of Recordings With Successful First Time Transmission | 49 percentage of first time transmissions |
| Home User Trial Phase 2 (HUT2) | Percentage of Recordings With Successful First Time Transmission | 76.7 percentage of first time transmissions |
| Home User Trial Phase 3 (HUT3) | Percentage of Recordings With Successful First Time Transmission | 96.7 percentage of first time transmissions |