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临床试验/NCT03523013
NCT03523013已完成不适用

The Outcome of CPAP Titration Under Sleep Endoscopy: A Randomized Controlled Crossover Trial

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年2月1日最近更新:
适应症

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

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)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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