Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Other: Neo App

• Registration Number: NCT04912635
• Lead Sponsor: ResMed

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-25
• Primary Completion: 2020-12-19
• Study Completion: 2021-03-25
• Status Verified: 2021-05
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Last Update Submitted: 2021-05-28
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Neo App	-

Primary Outcome Measures

Name	Time	Method
Mean CPAP use hours	6 weeks	Mean PAP use hours (mean hours per day) at 6 weeks following enrollment into the study compared to the control group.

Secondary Outcome Measures

Name	Time	Method
App Use	6 weeks	Percentage of participants that actively use the Neo app as determined by daily active users, weekly active users and time spent in the app.

Trial Locations

Locations (1)

ResMed; 🇦🇺 Bella Vista, New South Wales, Australia