Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Christian Seiler, University Hospital Inselspital, Berne Identifier:
First received: January 29, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

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.

Condition Intervention
Obstructive Sleep Apnea
Device: PFO Closure

Study Type: Interventional
Official Title: Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea

Resource links provided by NLM:

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up) [ Time Frame: 0, 3 months ]

Secondary Outcome Measures:
  • Systemic vascular assessment [ Time Frame: 0, 3 months ]

Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: OSA without PFO
OSA with PFO
PFO closure
Device: PFO Closure


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01780207

Contact: Stefano Rimoldi, MD +41316322111

University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Stefano Rimoldi, MD    +41316322111   
Sub-Investigator: Stefano Rimoldi, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
  More Information

No publications provided

Responsible Party: Christian Seiler, MD Prof, University Hospital Inselspital, Berne Identifier: NCT01780207     History of Changes
Other Study ID Numbers: 066/10
Study First Received: January 29, 2013
Last Updated: January 29, 2013
Health Authority: Switzerland: Ethikkomission

Additional relevant MeSH terms:
Foramen Ovale, Patent
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic processed this record on October 23, 2014