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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HUT1 | First phase of the home user trial. 19 users, 12 who were part of a couple and 7 who were single. | ||
| HUT2 | 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 | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At least 10 nights |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | For at least 10 nights of recordings |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 60 volunteers, all naïve to the device. The majority of the volunteers to be >65 years old, to represent the likely user profile: person with a set of chronic diseases, and not necessarily technically adept
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| Name | Affiliation | Role |
|---|---|---|
| Paul Phillips, MA, MSc | ResMed Sensor Technologies Ltd | Principal Investigator |
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Trial to validate the user features of the new medical device. Trial registered with ClinicalTrials.gov only because it involves human volunteers. No plans to publish
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Home User Trial Phase 1 (HUT1) | First phase of the home user trial. |
| FG001 | 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. |
| FG002 | Home User Trial Phase 3 (HUT3) | Third phase of home user trial, testing the final improvements to the device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Home User Trial Phase 1 (HUT1) | First phase of the home user trial. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of nights' data | At least 10 nights |
|
10 days during which the device was being used in the home environment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home User Trial Phase 1 (HUT1) | First phase of the home user trial. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Phillips | ResMed | +44 7789633508 | paul.phillips@resmed.com |
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| BG002 | Home User Trial Phase 3 (HUT3) | Third phase of home user trial, testing the final improvements to the device. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Part of a Couple | Count of Participants | Participants |
|
| Single | Count of Participants | Participants |
|
| OG002 | Home User Trial Phase 3 (HUT3) | Third phase of home user trial, testing the final improvements to the device. |
|
|
| 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 | Posted | Number | percentage of first time transmissions | For at least 10 nights of recordings |
|
|
|
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Home User Trial Phase 3 (HUT3) | Third phase of home user trial, testing the final improvements to the device. | 0 | 18 | 0 | 18 | 0 | 18 |
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