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临床试验/NCT04626700
NCT04626700Unknown不适用

Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月14日最近更新:
适应症

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

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

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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