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:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT02771561
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older
* Diagnosis of obstructive sleep apnoea-hypopnoea syndrome (OSAHS)
* Epworth Sleepiness Scale score of 11 or greater
* Oxygen Desaturation Index of 20 or greater (and/or oxygen desaturation index/apnoea-hypopnoea index greater than 0.67)
* Naive to Continuous Positive Airway Pressure (CPAP) treatment, or CPAP intolerant (defined at any review as: CPAP use less than 4 hours per night and unable to tolerate/receive no benefit, or at clinical discretion), or poor CPAP responders (defined at any review as: failure to improve Epworth Sleepiness Scale score by more than 4 points from Epworth Sleepiness Scale score at diagnostic visit plus persistent symptoms suggesting poorly controlled OSAHS and/or a prior failure to tolerate CPAP therapy)
* Moderate to large Patent Foramen Ovale (PFO) as seen on a transthoracic echocardiogram bubble study
CPAP naive patients with moderate-large PFO will start CPAP treatment during the study, but outcomes will be assessed at baseline (before starting CPAP treatment) and at six months post PFO closure (after one week of CPAP abstinence).
Exclusion Criteria:
* Coexistent significant respiratory disease (FEV1 \<50% predicted)
* Weight \>180kg (maximum weight allowance for echocardiogram table)
* Known or suspected pregnancy
* Other cardiac disease (valve disease, known cardiomyopathy, left ventricular failure, known congenital heart disease)
* Previous atrial septal closure device
* Inability to give informed consent or comply with the protocol
* Anatomically unsuitable for percutaneous PFO closure with Gore™ septal occluder device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02771561
Study Brief:
Protocol Section:
NCT02771561