Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT01780207
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients with newly diagnosed moderate to severe OSA
- Age > 17 years
- Written informed consent for study participation.
Exclusion Criteria
- Patients with other pulmonary disease associated with oxygen desaturation (other than obesity-associated pulmonary restriction)
- Patients with central sleep apnea syndrome
- Patients with other causes of pulmonary hypertension
- Intracardiac shunt other than via PFO
- Severe valvular heart disease
- Abnormal left ventricular (LV) systolic function (ejection fraction <50%)
- Obesity with BMI > 40
- Contraindication to TOE
- Severe pulmonary arterial hypertension (mean pulmonary artery pressure > 45 mmHg)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up) 0, 3 months
- Secondary Outcome Measures
Name Time Method Systemic vascular assessment 0, 3 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link PFO closure to improved systemic vascular function in OSA patients with PFO?
How does percutaneous PFO closure in NCT01780207 compare to CPAP therapy in reducing AHI and nocturnal hypoxemia in OSA patients with PFO?
Which biomarkers correlate with response to PFO closure in OSA patients with concomitant systemic vascular dysfunction?
What are the potential adverse events of percutaneous PFO closure in OSA patients with PFO, as assessed in NCT01780207?
How does PFO closure in OSA patients with PFO influence endothelial function and arterial stiffness compared to untreated cohorts?
Trial Locations
- Locations (1)
University Hospital Bern
🇨🇭Bern, Switzerland
University Hospital Bern🇨🇭Bern, Switzerland