Sleep Apnea, ObstructiveNCT04912635
Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
A study testing Neo App in people with Sleep Apnea, Obstructive, run by ResMed at 1 site in Australia.
Trial summary
This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and activity (steps). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Neo App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Sep 2020to 25 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is at least 18 years old.
- Participant is using a ResMed AirSense 10 device and ResMed myAir mobile app.
- Participant has been using CPAP therapy for less than 2 weeks.
- Participant has been enrolled in myAir for less than 2 weeks.
- Participants have self-reported resistant hypertension and they take 3 or more drugs to treat their hypertension.
- Participant owns a mobile device compatible with the Neo app (Android Jelly Bean, v16, 4.1.x or newer, and iOS 8 or newer)
Show all 10Show fewer
- Participant is somewhat to fairly confident about being able to use Bluetooth connected devices and apps
- Participant consents to download the Neo app, Withings app, create a Withings account, and sync Withings data to ResMed's Project Neo.
- Willing and able to give informed consent
- Can read and comprehend written and spoken English
Who cannot join
- Are participating in another app-based research study
- Cannot participate for the full duration of the study (at least 45 days)
- Unable to read or write English
- Participant is pregnant
- Participant is on Medicare
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and activity (steps).
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Neo App
- 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.
Neo AppOther
Neo is a smartphone-based dashboard application that utilizes concepts from behavioral science and health psychology to support patients to improve their adherence to therapy. This is done through behavior change techniques and intervention functions (Michie, Atkins \& West, 2014). This app is designed to prompt participants' self-regulation of lifestyle and health behaviors, to support adherence to therapy. Such self-regulation of lifestyle behaviors is informed by presenting health metric data (through wearables, myAir (biofeedback) and self-report), in an easy to understand dashboard platform on the app. Participants will be asked to use their PAP device (as normal), use a Withings blood pressure cuff and activity monitor. This data is brought into the Neo app through an API Exchange gateway. This data will be presented to the participant and communicated in an easy to understand way.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Other: Neo App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean CPAP use hours
Mean PAP use hours (mean hours per day) at 6 weeks following enrollment into the study compared to the control group.
Measured: 6 weeks
Secondary outcomes (1)
App Use
Percentage of participants that actively use the Neo app as determined by daily active users, weekly active users and time spent in the app.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start25 Sep 2020
- Primary completion19 Dec 2020
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912635
- Sponsor's protocol ID
- DHT-20-06-01
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
- ClinicalTrials.gov ID
- NCT04912635
- Acronym / sponsor ID
- DHT-20-06-01
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 3 Jun 2021 (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.
This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and activity (steps).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Other: Neo App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is at least 18 years old.
- Participant is using a ResMed AirSense 10 device and ResMed myAir mobile app.
- Participant has been using CPAP therapy for less than 2 weeks.
- Participant has been enrolled in myAir for less than 2 weeks.
- Participants have self-reported resistant hypertension and they take 3 or more drugs to treat their hypertension.
Key exclusion criteria (5 listed)
- Are participating in another app-based research study
- Cannot participate for the full duration of the study (at least 45 days)
- Unable to read or write English
- Participant is pregnant
- Participant is on Medicare
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 |
|---|---|---|
| Neo AppNeo is a smartphone-based dashboard application that utilizes concepts from behavioral science and health psychology to support patients to improve their adherence to therapy. This is done through behavior change techniques and intervention functions (Michie, Atkins \& West, 2014). This app is designed to prompt participants' self-regulation of lifestyle and health behaviors, to support adherence to therapy. Such self-regulation of lifestyle behaviors is informed by presenting health metric data (through wearables, myAir (biofeedback) and self-report), in an easy to understand dashboard platform on the app. Participants will be asked to use their PAP device (as normal), use a Withings blood pressure cuff and activity monitor. This data is brought into the Neo app through an API Exchange gateway. This data will be presented to the participant and communicated in an easy to understand way. | Other | Intervention |
Primary outcome
Mean CPAP use hours
Time frame: 6 weeks
Mean PAP use hours (mean hours per day) at 6 weeks following enrollment into the study compared to the control group.
1 secondary outcome
App Use
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neo App in people with Sleep Apnea, Obstructive, 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 10 inclusion and 5 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 3 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean CPAP use hours (time frame: 6 weeks). 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 3 Jun 2021.