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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Seiler, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01780207
First received: January 29, 2013
Last updated: December 29, 2014
Last verified: December 2014
  Purpose
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 ]

Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: OSA without PFO
OSA with PFO
PFO closure
Device: PFO Closure

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Criteria

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 ClinicalTrials.gov identifier: NCT01780207

Locations
Switzerland
University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Seiler, MD Prof, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01780207     History of Changes
Other Study ID Numbers: 066/10 
Study First Received: January 29, 2013
Last Updated: December 29, 2014
Health Authority: Switzerland: Ethikkomission

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Anoxia
Foramen Ovale, Patent
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 29, 2016