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

NCT04912635 | Completed

• 1 other identifier: DHT-20-06-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (1)

• App Use

  6 weeks

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

Other: Neo App

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

ResMed

Bella Vista, New South Wales, 2153, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: September 25, 2020
• Primary Completion: December 19, 2020
• Study Completion: March 25, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-05

Locations

AU (1)