NCT01780207已完成不适用
Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed moderate to severe OSA
- •Age > 17 years
- •Written informed consent for study participation.
排除标准
- •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)
结局指标
主要结局
Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up)
时间窗: 0, 3 months
次要结局
- Systemic vascular assessment(0, 3 months)
研究者
Christian Seiler
MD Prof
Insel Gruppe AG, University Hospital Bern
研究点 (2)
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