New auto-adjusting PAP algorithm for obstructive sleep apnea
Official title: Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
Run by ResMed · NCT06769607 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | ResMed Industry-sponsored |
| Locations | 1 site (Bella Vista, New South Wales) |
| Status | Recruiting |
| Started | April 10, 2025 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT06769607 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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ResMed Ltd
Bella Vista, New South Wales, Australia Recruiting
Study contacts
- Study coordinator: Sumudu Herath
- Email: sumudu.herath@resmed.com.au
- Phone: +61 288841722
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.