New auto-adjusting PAP algorithm for obstructive sleep apnea
Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
This test will try a new auto-adjusting PAP algorithm in adults with obstructive sleep apnea who already use ResMed AirSense 10 or 11 devices in AutoSet (APAP) mode.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ResMed Industry-sponsored |
| Locations | 1 site (Bella Vista, New South Wales) |
| Trial ID | NCT06769607 on ClinicalTrials.gov |
What this trial studies
This blind, randomized crossover (or single-arm in the early phase) home-based study compares a novel auto-adjusting PAP algorithm with an established control algorithm in adults with obstructive sleep apnea who are established PAP users. Phase 1 is designed to confirm the algorithm functions as intended and allow minor software adjustments, while Phase 2 enrolls a broader participant group to collect objective device data and subjective user feedback. Participants will primarily use the devices at home and may be asked to wear a wearable during day and night for the study duration. Those who prefer the investigational algorithm after the main phases may opt into an optional extended use period.
Who should consider this trial
Good fit: Adults (≥18) who have been on PAP therapy for roughly >3 months, currently use ResMed AirSense 10 or 11 devices in AutoSet (APAP) mode, can read English, and can commit to up to eight weeks of participation are ideal candidates.
Not a fit: People using bilevel flow generators, CPAP AutoSet for Her mode, who are pregnant, or who have certain lung diseases that increase pneumothorax risk are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the algorithm could improve nightly breathing control and comfort by adjusting pressure more responsively, which may reduce symptoms and improve sleep quality.
How similar studies have performed: Modifications to APAP algorithms have shown mixed but often positive effects on breathing control and comfort in prior work, but this specific algorithm is novel and requires direct testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants willing to give written informed consent. * Participants who can read and comprehend English. * Participants who ≥ 18 years of age * Participants who have been using a ResMed AirSense 10 or 11 device. * Participants currently using AutoSet (APAP) mode. * Participants being established on PAP therapy for the treatment of OSA for approximately \>3 months. * Participants who can participate in the study for up to 8 weeks. Exclusion Criteria: * Participants using Bilevel flow generators. * Participants using CPAP, AutoSet for Her * Participants who are or may be pregnant. * Participants 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. * Participants believed to be unsuitable for inclusion by the researcher. * Participants who are currently enrolled in other medical clinical studies
Where this trial is running
Bella Vista, New South Wales
- ResMed Ltd — Bella Vista, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Sumudu Herath
- Email: sumudu.herath@resmed.com.au
- Phone: +61 288841722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.