Medical vs Surgical Treatment Decision in Pediatric Obstructive Sleep Apnea Using Sleep Questionnaire
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy
研究概览
简要总结
Adeno-tonsillar hypertrophy causing OSA are treated surgically however, over the last years it has been shown that montelukast or nasal steroidal spray can significantly improve symptoms, adenoid size, and polysomnographic results in pediatric non-severe OSA, excluding the need for surgery. A literature review from 2016 suggested that by using anti-leukotrienes as anti-inflammatory appears to be beneficial in children with a non-severe OSA and can be offered to parents as a treatment option before, or instead of surgery. In addition, nasal steroidal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy [9]. Despite emerging evidence that both montelukast and nasal steroids are effective in the treatment of pediatric SDB, further evidence is still required. . adeno-tonsillar hypertrophy causing OSA are treated surgically however, over the last years it has been shown that montelukast or nasal steroidal spray can significantly improve symptoms, adenoid size, and polysomnographic results in pediatric non-severe OSA, excluding the need for surgery. A literature review from 2016 suggested that by using anti-leukotrienes as anti-inflammatory appears to be beneficial in children with a non-severe OSA and can be offered to parents as a treatment option before, or instead of surgery. In addition, nasal steroidal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy. Despite emerging evidence that both montelukast and nasal steroids are effective in the treatment of pediatric SDB, further evidence is still required.
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 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children between 2-16 years of age referred to the pediatric otolaryngology outpatient clinic due to OSA and have not undergone previous adeno-tonsillar procedure
排除标准
- •children with severe OSA who need an urgent surgery and cannot be postponed, children with nasal polyposis, craniofacial malformations (e.g. cleft lip and palate), and genetic diseases (e.g. Down syndrome).
研究组 & 干预措施
Montelukast tab
干预措施: Montelukast (Drug)
Fluticasone nasal spray
干预措施: Fluticasone Furoate (Drug)
结局指标
主要结局
To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy
时间窗: 1 year
次要结局
- To determine clinical response to montelukast or nasal steroids based on PSQ results(1 year)
