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OpenTrials
Completed

NCT Number: NCT01780207

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PFO closure

Device

Primary outcomes

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

    Time frame: 0, 3 months

Secondary outcomes

  1. Systemic vascular assessment

    Time frame: 0, 3 months

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Primary completion
2014
First posted
Jan 30, 2013
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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