Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00850434
Eligibility Criteria:
Inclusion Criteria:
* PSG-confirmed diagnosis of OSA, showing an apnoea-hypopnoea index (AHI) of at least 15 events/hr and an obstructive apnoea index (OAI) of at least 5 events/hr.
* On CPAP therapy (fixed pressure or autoCPAP) for at least 1 month.
* Using a ResMed mask (this requirement applies only to phase 2 of the trial) without significant discomfort for at least 2 weeks.
* Age between 18 and 70 years.
* Written informed consent.
Exclusion Criteria:
* Unstable medical condition, including unstable angina, myocardial infarction within previous 6 months, cardiac failure NYHA grades III and IV, epilepsy, psychiatric disturbance.
* Respiratory insufficiency, defined as arterial CO2 greater than 50 mm Hg during the daytime or arterial oxygen saturation less than 90% when asleep and breathing room air on effective CPAP therapy.
* Recent severe epistaxis.
* History of spontaneous pneumothorax.
* History of regurgitation of gastric contents during sleep.
* Unable to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00850434
Study Brief:
Protocol Section:
NCT00850434