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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

NCT ID: NCT01780207

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Groups

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OSA without PFO

Group Type NO_INTERVENTION

No interventions assigned to this group

OSA with PFO

PFO closure

Group Type OTHER

PFO Closure

Intervention Type DEVICE

Interventions

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PFO Closure

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Christian Seiler

MD Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Bern

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 26418025 (View on PubMed)

Other Identifiers

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066/10

Identifier Type: -

Identifier Source: org_study_id