Ease of UseNCT02740517
Usability Evaluation - Reassure Respiration Rate Device: Home User Study
An observational study of Ease of Use, run by ResMed.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Ease of Use
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- volunteer, no previous exposure to the device
Who cannot join
- restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep
About this study
Official title: 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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least 10 nights
Secondary outcomes (1)
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
Measured: For at least 10 nights of recordings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ease of UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Phillips, MA, MSc, Principal investigator, ResMed Sensor Technologies Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740517
- Sponsor's protocol ID
- D22105-115
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2016
- Last updated
- 7 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reassure Respiration Rate Device: Home User Study
- ClinicalTrials.gov ID
- NCT02740517
- Acronym / sponsor ID
- D22105-115
- Conditions
- Ease of Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 7 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- volunteer, no previous exposure to the device
Key exclusion criteria (1 listed)
- restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Percentage of Recordings With Successful First Time Transmission
Time frame: For at least 10 nights of recordings
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Phillips, MA, MSc principal investigator
ResMed Sensor Technologies Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Ease of Use, run by ResMed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Nights' Data That Were Successfully Recorded (time frame: At least 10 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.