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NCT01780207 Clinical Trial

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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01780207
Other study ID # 066/10
Secondary ID
Status Completed
Phase N/A
First received January 29, 2013
Last updated December 29, 2014

Study information
Verified date December 2014
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkomission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date May 2014
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Device:
• PFO Closure

Locations
Country Name City State
Switzerland University Hospital Bern Bern

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up) 0, 3 months
Secondary Systemic vascular assessment 0, 3 months
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