Personal Therapy Comfort Settings Pilot Clinical Study

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: continuous positive airway pressure (CPAP)

• Registration Number: NCT05376137
• Lead Sponsor: ResMed

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Study Start: 2022-09-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Default comfort settings	continuous positive airway pressure (CPAP)	Comfort settings will be set to default (out of the box setttings)
Personalized Therapy Comfort Settings	continuous positive airway pressure (CPAP)	Comfort settings will be personalized to each user

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ResMed Centre for Healthy Sleep; 🇦🇺 Bella Vista, New South Wales, Australia