NCT02523248终止不适用
Randomized Control Study Between Uvulopalatopharyngoplasty and Tonsillectomy in Adult Sleep Apnea Patients
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
研究概览
简要总结
The aim of this randomized control study is to evaluate the effect of tonsillectomy with or without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.
详细描述
Patients are after baseline PSG 1 included and randomized to either UPPP or TE. They are stratified according to tonsil size, those with size 2 in one group and those with 3-4 in another. They all undergo surgery within two months and thereafter PSG 2 after 6 months and PSG after 4 years. At PSG they fill in questionnaires and measurements of blood pressure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI more than 15
- •Friedmans stage I and II
- •Tonsil size 2, 3 and 4
- •BMI below 34
- •Failed use of CPAP and dental device
排除标准
- •Severe cardiovascular or neurological disease
- •Prefers strongly one surgical method
结局指标
主要结局
Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
时间窗: 6 months
measurements with inlab polysomnography
次要结局
- Group differences in changes of blood pressure(6 months)
- Questionnaire: group differences of changes in daytime sleepiness(6 months)
- Questionnaire: group differences in changes of general health(6 months)
研究者
Danielle Friberg
Associate Professor
Karolinska University Hospital
研究点 (2)
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