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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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
PFO Closure
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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)

Sites / Locations

  • University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

OSA without PFO

OSA with PFO

Arm Description

PFO closure

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up)

Secondary Outcome Measures

Systemic vascular assessment

Full Information

First Posted
January 29, 2013
Last Updated
December 29, 2014
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01780207
Brief Title
Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
OSA without PFO
Arm Type
No Intervention
Arm Title
OSA with PFO
Arm Type
Other
Arm Description
PFO closure
Intervention Type
Device
Intervention Name(s)
PFO Closure
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up)
Time Frame
0, 3 months
Secondary Outcome Measure Information:
Title
Systemic vascular assessment
Time Frame
0, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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)
Facility Information:
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26418025
Citation
Rimoldi SF, Ott S, Rexhaj E, de Marchi SF, Allemann Y, Gugger M, Scherrer U, Seiler C. Patent Foramen Ovale Closure in Obstructive Sleep Apnea Improves Blood Pressure and Cardiovascular Function. Hypertension. 2015 Nov;66(5):1050-7. doi: 10.1161/HYPERTENSIONAHA.115.06303. Epub 2015 Sep 21.
Results Reference
derived

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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

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