Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- apnea-hypopnea index (AHI)
研究概览
简要总结
This is the study entitled "Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Recent study reveals that oral negative pressure therapy improves apnea severity in OSA patients with good compliance. However, no study is designed to compare oral negative pressure therapy and CPAP for OSA patients. In addition, the effect of oral negative pressure therapy for hypopharynx is unclear. Therefore, we will perform druginduced sleep endoscopy to evaluate upper airway obstruction of OSA patients before treatment. OSA patients will be assigned into oral negative pressure group or CPAP group for 2 months. Sleepiness, sleep quality, residual apnea severity and compliance will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate OSA
排除标准
- •hypopharynx obstruction
- •ASA classification of physical status)>3
- •allergy toDexmedetomidine
- •COPD stage IV
- •Asthma with exacerbation
- •severe CHF
- •age < 18 year-old
- •claustraphobia
- •any reason : can not tolerate CPAP
- •second or third degree AVB
结局指标
主要结局
apnea-hypopnea index (AHI)
时间窗: Change from Baseline AHI at 2 months
lower AHI means better outcome
The Epworth Sleepiness Scale (ESS)
时间窗: Change from Baseline ESS at 2 months
lower ESS means better outcome
次要结局
未报告次要终点
