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

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).

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ResMed

Bella Vista, New South Wales, 2153, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neo App

Other

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 outcomes

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.

Secondary outcomes

App Use

Time frame: 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.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Jun 3, 2021
Registry last updated: Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed