Obstructive Sleep ApneaNCT04500327
An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
A study testing Drive app and Non contact motion sensor in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the usability and suitability of the Drive app (app under test) to measure sleep parameters during CPAP use. This is a prospective, non-randomized, single arm exploratory study without blinding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Drive app and Non contact motion sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Jun 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants who ≥ 18 years of age
- Participants established on CPAP therapy for the treatment of OSA for ≥ 6 months
- Participants who are able to set up the trial devices (ideally on a bedside table) with the following criteria:
- Trial devices must be 10 cm higher than the mattress
Show all 11Show fewer
- Approx. 40 cm from the person's chest in bed
- Participants that have access to WI-FI in their home environment
- Participants who can trial the device for up to 7 nights
- *Participants who have been compliant (average of ≥4 hours of usage) to therapy for up to 7 nights of use
- Note: the most recent consecutive 7 nights within the last 30 days
Who cannot join
- Participants using Bilevel flow generators
- Participants who are or may be pregnant, breastfeeding or within 6 weeks postpartum (which are known to cause significant sleep disruption)
- Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
- Participants believed to be unsuitable for inclusion by the researcher
- *Participants using one of the following devices or Apps during the research period, or any other sleep tracking devices: SPlus, SleepScore app, SleepScore Max.
- Note: If the participant uses the devices or apps above and they agree to delete/not use them during study period, they can be included in the study.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
ResSleep
Sydney, New South Wales, 2153
Neha Banodkar
About this study
The purpose of this study is to evaluate the usability and suitability of the Drive app (app under test) to measure sleep parameters during CPAP use.
This is a prospective, non-randomized, single arm exploratory study without blinding.
Read more
Current users of CPAP therapy will be recruited for this study and will be provided with a smartphone (app under test installed) and a non-contact motion sensor in their home environment. These devices will measure sleep metrics such as sleep stages and breathing metrics that may be associated with sleep disordered breathing. Usage and setup instructions will be provided for the study.
Participants will contribute up to 7 overnight recordings in the home environment and will complete daily questionnaires detailing their experience.
The study may be completed in two distinct phases, with an analysis performed after each phase. Each phase is expected to last up to six weeks with the overall study duration taking up to 12 months.
Read the detailed description
The study may be completed in two distinct phases, with an analysis performed after each phase.
Phase 1 (Exploratory): A minimum of 10 and up to 12 participants will be recruited to identify any issues in using the app when used in conjunction with CPAP therapy (e.g. missed signals, inappropriate classification of breathing signals).
Phase 2 (Iterative Updates): Where changes to the algorithm or user interface are required, an additional 30 and up to 35 participants may be tested to provide design confidence. Conversely, if substantial issues are experienced and the time and effort required to address the issues is sufficiently large, the study may terminate before completion of phase 2.
Each phase is expected to last up to six weeks with the overall study duration taking up to 12 months.
Participants will be required to visit ResMed twice. The first visit will involve briefing of the study, consent form signatures, briefing on trial equipment and setup/usage instructions. The second (last) visit will involve going through the daily questionnaires with participants, collecting trial equipment and providing reimbursement for the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Drive app, Non contact motion sensor
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drive appOther
The Drive app will be used to monitor sleep metrics for users of CPAP therapy.
Non contact motion sensorDevice
The non contact motion sensor will be used as a reference to the Drive app i.e. Drive app overnight recordings will be compared to the non contact motion sensor overnight recordings.
| Study group | Role | What they receive |
|---|---|---|
| CPAP users | Experimental | The Drive app will be used by CPAP users to identify any major issues with the usability and functionality of the app when used with CPAP therapy. Receives: Other: Drive app; Device: Non contact motion sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify any failures when using the Drive app for users of CPAP therapy
This will be based on:
- Subjective data from daily questionnaires sent out to participants
- Comparison between Drive app data with the non contact motion sensor and CPAP data
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
Measured: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Secondary outcomes (3)
Evaluate usability of the Drive app
This will be based on subjective data from daily questionnaires sent out to participants.
This data will be captured from comments by the participants in the daily questionnaires.
Measured: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Compare subjective sleep quality data with data generated on the app.
This will be based on subjective data from daily questionnaires sent out to participants.
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.
Measured: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Compare the Drive app sleep data to data from the reference devices.
Analyses will be performed to compare the Drive app data with the non contact motion sensor and CPAP device.
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
Measured: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start25 Jun 2020
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500327
- Sponsor's protocol ID
- DHT-20-04-01
- Status last verified
- Jul 2020
- First submitted
- 26 May 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
- ClinicalTrials.gov ID
- NCT04500327
- Acronym / sponsor ID
- DHT-20-04-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the usability and suitability of the Drive app (app under test) to measure sleep parameters during CPAP use.
This is a prospective, non-randomized, single arm exploratory study without blinding.
Current users of CPAP therapy will be recruited for this study and will be provided with a smartphone (app under test installed) and a non-contact motion sensor in their home environment. These devices will measure sleep metrics such as sleep stages and breathing metrics that may be associated with sleep disordered breathing. Usage and setup instructions will be provided for the study.
Participants will contribute up to 7 overnight recordings in the home environment and will complete daily questionnaires detailing their experience.
The study may be completed in two distinct phases, with an analysis performed after each phase. Each phase is expected to last up to six weeks with the overall study duration taking up to 12 months.
Detailed description
The study may be completed in two distinct phases, with an analysis performed after each phase.
Phase 1 (Exploratory): A minimum of 10 and up to 12 participants will be recruited to identify any issues in using the app when used in conjunction with CPAP therapy (e.g. missed signals, inappropriate classification of breathing signals).
Phase 2 (Iterative Updates): Where changes to the algorithm or user interface are required, an additional 30 and up to 35 participants may be tested to provide design confidence. Conversely, if substantial issues are experienced and the time and effort required to address the issues is sufficiently large, the study may terminate before completion of phase 2.
Each phase is expected to last up to six weeks with the overall study duration taking up to 12 months.
Participants will be required to visit ResMed twice. The first visit will involve briefing of the study, consent form signatures, briefing on trial equipment and setup/usage instructions. The second (last) visit will involve going through the daily questionnaires with participants, collecting trial equipment and providing reimbursement for the study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP users | Experimental | Other: Drive app, Device: Non contact motion sensorThe Drive app will be used by CPAP users to identify any major issues with the usability and functionality of the app when used with CPAP therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants who ≥ 18 years of age
- Participants established on CPAP therapy for the treatment of OSA for ≥ 6 months
- Participants who are able to set up the trial devices (ideally on a bedside table) with the following criteria:
Key exclusion criteria (6 listed)
- Participants using Bilevel flow generators
- Participants who are or may be pregnant, breastfeeding or within 6 weeks postpartum (which are known to cause significant sleep disruption)
- Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
- Participants believed to be unsuitable for inclusion by the researcher
- *Participants using one of the following devices or Apps during the research period, or any other sleep tracking devices: SPlus, SleepScore app, SleepScore Max.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drive appThe Drive app will be used to monitor sleep metrics for users of CPAP therapy. | Other | CPAP users |
| Non contact motion sensorThe non contact motion sensor will be used as a reference to the Drive app i.e. Drive app overnight recordings will be compared to the non contact motion sensor overnight recordings. | Device | CPAP users |
Primary outcome
Identify any failures when using the Drive app for users of CPAP therapy
Time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
This will be based on: 1. Subjective data from daily questionnaires sent out to participants 2. Comparison between Drive app data with the non contact motion sensor and CPAP data The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire. Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
3 secondary outcomes
Evaluate usability of the Drive app
Time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Compare subjective sleep quality data with data generated on the app.
Time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Compare the Drive app sleep data to data from the reference devices.
Time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drive app and Non contact motion sensor in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neha Banodkar ((02) 8884 2656, neha.banodkar@resmed.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify any failures when using the Drive app for users of CPAP therapy (time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)). 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 5 Aug 2020.