Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome (OSAS) in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment:
研究概览
简要总结
The aim of the project is to evaluate whether therapy with leukotriene may be a valid therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally or more efficient than nasal steroid.
详细描述
The aim of the project is to evaluate whether leukotriene is less, equally or more efficient than nasal steroid in children with adenotonsillar hypertrophy and with mild and moderate OSAS checking if leukotriene administrated for 24 weeks improves overnight oximetry, polysomnography and checking if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions.
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
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild (RDI 3- <5) or moderate obstructive apneas (RDI 5-8) by overnight polysomnographic evaluation with 4 channels EEG
- •Adenotonsillar hypertrophy Friedman score's II-III-IV°
排除标准
- •Neuromuscular, gastrointestinal, neurological diseases and syndromes of malformations
- •Use of leukotrienes and/or nasal and oral steroids in the 4 weeks preceding the initial sleep study
- •Acute upper respiratory tract infections
- •Adenotonsillectomy
研究组 & 干预措施
Nasal steroid
干预措施: budesonide (Aircort 50 nasal spray) (Drug)
Anti-leukotrienes
干预措施: montelukast (Singulair) (Drug)
Nasal steroid + anti-leukotrienes
干预措施: budesonide (Aircort 50 nasal spray) (Drug)
Nasal steroid + anti-leukotrienes
干预措施: montelukast (Singulair) (Drug)
结局指标
主要结局
Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment:
时间窗: 1 year
次要结局
- To evaluate the clinical upper airway patency during the night in the patients with history of allergic rhinitis compared with the patients without history of allergic rhinitis first and after the treatment for OSAS(1 year)
研究者
Filippo Bernardi
Associate Professor
University of Bologna