RecruitingNot ApplicableNCT06769607
Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
Sponsor
ResMed
Enrollment
80 participants
Start Date
Apr 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria6
- 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
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Interventions
DEVICEInvestigational algorithm
Investigational algorithm developed for the treatment of Obstructive Sleep Apnea.
DEVICEControl algorithm
Released algorithm intended for the treament of Obstructive Sleep Apnea
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06769607
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