Personal Therapy Comfort Settings Pilot Clinical Study

350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment.

User accessible customizable comfort settings (Response setting, expiratory pressure relief (EPR) on/off and EPR level, and Ramp) will be set to either default (control group), or personalized for that participant (active treatment group).

Usage will be recorded for the first 1 month of CPAP treatment, to determine if customizing comfort settings can improve CPAP compliance

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: continuous positive airway pressure (CPAP)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Bella Vista, New South Wales, Australia, 2153
      • ResMed Centre for Healthy Sleep

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients willing to give written informed consent
• Patients who can read and comprehend English
• Patients who are ≥ 18 years of age
• Patients newly diagnosed with OSA and indicated for CPAP therapy.

Exclusion Criteria:

• Patients who have previously used PAP therapy
• Patients who require a bilevel device

• Patients who are or may be pregnant

  * Patients who are unable to attend follow up appointments

• Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury
• Patients believed to be unsuitable for inclusion by the researcher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Default comfort settings; Comfort settings will be set to default (out of the box setttings)	Device: continuous positive airway pressure (CPAP); CPAP comfort settings will be modified in the active group to be personalized to each participant
Experimental: Personalized Therapy Comfort Settings; Comfort settings will be personalized to each user	Device: continuous positive airway pressure (CPAP); CPAP comfort settings will be modified in the active group to be personalized to each participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of treatment continuance between the control group and active treatment group.	Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment.	4 weeks after commencement of CPAP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of compliance between the control group and active treatment group	Usage will be compared between the two groups	4 weeks after commencement of CPAP
Treatment efficacy	Residual Apnea-hypopnea index will be compared between the two groups	4 weeks after commencement of CPAP
Mask leak	Mask leak will be compared between the two groups	4 weeks after commencement of CPAP
Settings changes	Number of comfort settings changes will be compared between the two groups	4 weeks after commencement of CPAP
Ad hoc contacts	Number of ad hoc contacts between participants and clinicians will be compared between the two groups	4 weeks after commencement of CPAP

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory analysis of long term usage	CPAP usage will be compared at 3, 6, 9 and 12 months for patients who have consented, as an exploratory analysis of long term usage	3,6,9, 12 months after commencement of CPAP

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Jeff Armitstead, PhD, ResMed

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: MA11022022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No