Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Obstructive Apnea Hypopnea Index
研究概览
简要总结
This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy, duration of action and side-effects will be determined.
详细描述
Several studies have suggested that Nasal corticosteroids (NCS) or leukotriene antagonists may be effective in the treatment of childhood OSAS. However, these studies have been limited by factors such as small size, lack of randomization and blinding, short-term follow-up, involvement of children with only very mild OSAS, and/or lack of stratifying for the presence of atopy. Therefore, investigators will plan a randomized controlled trial evaluating the efficacy and safety of NCS vs placebo in children with mild to moderate OSAS. The overall hypothesis is that NCS will be safe and efficacious in the treatment of mild to moderate childhood OSAS, particularly in children with asthma/atopy, but will require ongoing maintenance therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nasal steroids
Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).
干预措施: Nasal Fluticasone (Drug)
Placebo
Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).
干预措施: Placebo (Drug)
结局指标
主要结局
Obstructive Apnea Hypopnea Index
时间窗: 3 months
Efficacy measure to assess acute response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome.
次要结局
- The Epworth Sleepiness Scale(12 months)
- Pediatric Quality of Life Inventory (PedsQL)(12 month)
- Behavior Rating Inventory of Executive Function (BRIEF)(12 months)
- Conners Abbreviated Symptom Questionnaire(12 months)
- Purdue Peg Board(12 months)
- Conners Continuous Performance Test (CPT)(12 months)
- OAHI(12 months)
- Nasal Obstruction Symptom Evaluation (NOSE)(12 months)
- Child Behavior Checklist(12-Months)