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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.
Verified January 2013 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
Christian Seiler, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01780207
First received: January 29, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780207

Contacts
Contact: Stefano Rimoldi, MD +41316322111 stefano.rimoldi@insel.ch

Locations
Switzerland
University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Stefano Rimoldi, MD     +41316322111     stefano.rimoldi@insel.ch    
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
ClinicalTrials.gov 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:
Apnea
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Septal Defects
 Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013