Patent Foramen Ovale Closure on Newly Diagnosed Patients with Obstructive Sleep Apnea and Refractory Hypoxia: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- change in duration of nocturnal oxygen desaturation duration.
研究概览
简要总结
The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with severe OSA, defined as an apnea-hypopnea index (AHI) greater than 30, associated with nocturnal saturation below 90%, as determined by a sleep medicine specialist using polysomnography.
- •Individuals need to have a patent foramen ovale documented by echocardiography.
排除标准
- •Individuals unable to take aspirin, clopidogrel, and/or ticagrelor.
- •Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
结局指标
主要结局
change in duration of nocturnal oxygen desaturation duration.
时间窗: baseline and then up to 3 months after the study
Will be measured in seconds.
changes in the apnea hypoxia index
时间窗: baseline and then up to 3 months after the study
The Apnea hypopnea index that ranges from: 0 to 5 is normal 5 to15 is mild 15 to 30 is moderate greater than 30 is severe.
change in mean nocturnal oxygen saturation
时间窗: baseline and then up to 3 months after the study
Oxygen saturation will be measured in percentage. Ranges from 0 to 100 percent. The higher the percent the higher the oxygen saturation.
次要结局
- change in quality of life as measured by the patient global impression of change scale.(baseline and then up to 3 months after the study)
- change in quality of sleep as measured by the Epworth Sleepiness Scale(baseline and then up to 3 months after the study)
- Change in physical activity as measured by Godin Leisure time physical activity questionnaire.(baseline and then up to 3 months after the study)
- change in fatigue as measured by the Fatigue Severity Scale.(baseline and then up to 3 months after the study)
- changes in functional independence measure(baseline and then up to 3 months after the study)
研究者
Eduardo De Marchena
Professor of Medicine and surgery
University of Miami