The Outcome of CPAP Titration Under Sleep Endoscopy: A Randomized Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- complaince of CPAP use
研究概览
简要总结
The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial
详细描述
This is the study entitled "The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is about 50%. One of the reasons responsible for the poor compliance is the inadequate pressure setting initially. Therefore, it is crucial for us to find out the adequate pressure as soon as possible. Sleep endoscopy is the way to evaluate upper airway obstruction of OSA patients. Meanwhile, the investigators used CPAP to titrate the adequate pressure to keep upper airway open under sleep endoscopy guidance. While the investigators find out this adequate pressure, the investigators set this pressure into CPAP program, which OSA patient will use for 1 month. To compare the different effect of CPAP under either auto-CPAP titration pressure or sleep endoscopy guidance pressure, those OSA patients will use auto-titration CPAP for 1 month as well. Another highlight of this study is the sedative agent-dexmedetomidine. Dexmedetomidine is a α2 antogonist, which cause patients sedative but less respiratory drive suppression. The mechanism of dexmedetomidine is more physiological for nature sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •moderate to severe OSA
排除标准
- •allergy to Dexmedetomidine
- •second or third degree AVB
- •severe heart failure Fc class IV
- •asthma acute attack
结局指标
主要结局
complaince of CPAP use
时间窗: the change of complaince between baseline, 1 month and 2 months
CPAP complaince was defined as the use of CPAP is more than 4 hours per day and 5 days per week
次要结局
- sleepiness score(the change of ESS between baseline, 1 month and 2 months)
