Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01780207
Recruitment Status :
First Posted : January 30, 2013
Last Update Posted : December 30, 2014
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Christian Seiler, University Hospital Inselspital, Berne
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Patients with newly diagnosed moderate to severe OSA
Age > 17 years
Written informed consent for study participation.
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%)