NCT05049369已完成不适用
Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults
详细描述
The investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. These patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. Especially the reduction in apnea-hypopnea index (AHI) will be evaluated. The quality of life and possible symptoms will be measured with questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age at least 16 during tonsillectomy
- •preoperative obstructive sleep apnea and AHI (apnea-hypopnea index) > 14
- •tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (ICD-10 diagnostic codes G47.3, R06.5 or J35.1)
- •in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate
排除标准
- •AHI < 14
- •in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement
- •other, evaluated by investigator
结局指标
主要结局
Apnea-hypopnea index
时间窗: 3-17 years
Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.
次要结局
- Quality of life measured by Epworth sleepiness scale (ESS)(3-17 years)
- Quality of life measured by Glasgow Benefit Inventory (GBI)(3-17 years)
- Apnea-index (AI)(3-17 years)
- Oxygen Desaturation Index (ODI)(3-17 years)
- Snoring time(3-17 years)
研究者
研究点 (2)
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