NCT01780207

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

First QC Date

January 29, 2013

Last Update Submit

December 29, 2014

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

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

    0, 3 months

Secondary Outcomes (1)

  • Systemic vascular assessment

    0, 3 months

Study Arms (2)

OSA without PFO

NO INTERVENTION

OSA with PFO

OTHER

PFO closure

Device: PFO Closure

Interventions

PFO ClosureDEVICE
OSA with PFO

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly diagnosed moderate to severe OSA
  • Age \> 17 years
  • Written informed consent for study participation.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 26418025DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Prof

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 30, 2013

Primary Completion

May 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

CH(1)