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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04912635




Registration number
NCT04912635
Ethics application status
Date submitted
28/05/2021
Date registered
3/06/2021
Date last updated
3/06/2021

Titles & IDs
Public title
Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
Scientific title
Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
Secondary ID [1] 0 0
DHT-20-06-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Neo App

No intervention: Control -

Experimental: Intervention -


Other interventions: Neo App
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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean CPAP use hours
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
App Use
Timepoint [1] 0 0
6 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/03/2021
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed - Bella Vista
Recruitment postcode(s) [1] 0 0
2153 - Bella Vista

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04912635
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04912635