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

December 29, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: OSA without PFO
OTHER: OSA with PFO
PFO closure
Device: PFO Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up)
Time Frame: 0, 3 months
0, 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Systemic vascular assessment
Time Frame: 0, 3 months
0, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (ESTIMATE)

January 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 066/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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