NCT00497120Unknown不适用
A Combined Surgical and Medical Approach in Mild Sleep Apnea
适应症
相关药物
试验速览
- 阶段
- 不适用
- 试验地点
- 2
- 主要终点
- Polysomnographic parameters
研究概览
简要总结
The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 ≤ Apnea Hypopnea Index (AHI) < 20
- •Socially disturbing snoring: Visual Analogue Scale (VAS)snoring > 6/10
- •Based on clinical examination and polysomnography, patient is regarded eligible for uvulopalatopharyngoplasty (UPPP)
排除标准
- •Previous surgical treatment for sleep-disordered breathing.
- •Periodic Limb Movement Disorder (PLMD) with arousals and other reasons possibly explaining the Excessive Daytime Sleepiness (EDS) based on Epworth Sleepiness Scale (ESS).
- •Forced expiratory volume in 1 second (FEV1) < 80 % pred.
- •Echocardiography: ejectionfraction < 35 % or dyastolic dysfunction grade 2 or more.
结局指标
主要结局
Polysomnographic parameters
次要结局
- subjective sleepiness
- subjective snoring
- satisfaction
研究者
研究点 (2)
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