Back to resultsEvaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Neo App
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea, Obstructive
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
Sites / Locations
- ResMed
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04912635
Brief Title
Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
Official Title
Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
December 19, 2020 (Actual)
Study Completion Date
March 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neo App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean CPAP use hours
Description
Mean PAP use hours (mean hours per day) at 6 weeks following enrollment into the study compared to the control group.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
App Use
Description
Percentage of participants that actively use the Neo app as determined by daily active users, weekly active users and time spent in the app.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
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
Facility Information:
Facility Name
ResMed
City
Bella Vista
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
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