Possible Efficacy of Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- More than 50% improvement in Apnea-Hypopnea index (AHI)
研究概览
简要总结
Obstructive Sleep apnea carries a variety of complications and implications. While the disease could be treated using continuous positive airway pressure (CPAP) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. The conventional surgical options to date ranges from radical (UPPP) to individualized, with or without Drug-induced sleep endoscopy (DISE). Previous studies showed that dise directed surgery can be useful for specific conditions. No trials were found to test in-office encompassing minimal invasive surgical treatment (RF palatoplasty , RF tonsillotomy, RF turbinectomy, and RF base-of-tongue reduction) as a viable alternative..
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from OSA, defined as AHI > 5
排除标准
- •Patients who can use CPAP.
- •Patients suffering from confounding factors with higher risk (Coagulation problems, Heart conditions, chronic obstructive pulmonary disease (COPD), or other dangerous conditions as decided by the surgeon)
- •Patients suffering from other problems aggravating the OSA (Respiratory, Neurologic conditions)
结局指标
主要结局
More than 50% improvement in Apnea-Hypopnea index (AHI)
时间窗: 12 months following the procedure
Measuring the AHI score using sleep laboratory
Reduction of AHI to below 20
时间窗: 12 months following the procedure
Measuring the AHI score using sleep laboratory
次要结局
未报告次要终点