Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in the number of apnea/hypopnea episodes during a sleep study
研究概览
简要总结
-Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in children with mild sleep apnea that would not be candidates for T&A.
详细描述
Untreated OSAS can result in serious morbidity, primarily affecting neurobehavioral and cardiovascular systems.
The severity of OSAS is only partially related to the adenoid and tonsillar size. While adenotonsillectomy (T&A) is the most common treatment for children with OSAS, this approach is reserved for children whose apnea/hypopnea index in the overnight sleep study exceeds a critical value. However, there is no consensus on the appropriate management of children with AHI >1 but <7 events/hour of sleep. These children constitute between 4-6% of all children and there are no alternative long-term interventions, and therefore a medical approach that obviates surgery, yet leads to substantial amelioration in the sleep-disordered breathing is critically needed.
Anti-inflammatory agents like intra-nasal corticosteroids are considered an effective treatment for children with allergic rhinitis. However, only one study has been conducted so far, and has examined the effect of intranasal corticosteroids, in pediatric patients with florid OSAS. Thus, no studies are available on topical steroids in patients with OSAS severity that would not justify T&A.
Our leading hypothesis is:
- Intranasal budesonide therapy may lead to improved symptoms and polysomnographic findings in children with OSAS with and without allergic rhinitis that would not be treated with T&A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children >6 years of age and < 12 years of age, who snore and have an apnea hypopnea index (AHI) < or equal 7 or Respiratory arousal index > or equal 2
排除标准
- •Hypersensitivity to budesonide
- •Recent nasal trauma
- •Nasal surgery or nasal septum perforation
- •Current therapy with drugs interacting with budesonide (erythromycin clarythromycin, ketoconazole and cimetidine)
- •Immunodeficiency or immunosuppressant therapy
- •Craniofacial, neuromuscular, syndromic or defined genetic abnormalities
- •Acute upper respiratory tract infection
- •Systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study, and
- •Children who already had adenotonsillectomy in the past 12 months.
研究组 & 干预措施
Budesonide
Budesonide for 6 weeks followed by crossover to placebo
干预措施: Budesonide (Drug)
Placebo
Placebo for 6 weeks followed by crossover to treatment.
干预措施: placebo (Drug)
结局指标
主要结局
Change in the number of apnea/hypopnea episodes during a sleep study
时间窗: Start of study, 6 weeks after drug treatment started and 6 weeks after placebo treatment started.
Subjects will complete a sleep study with polysomnography at beginning of treatment and 6 weeks after start of treatment. Analysis of the sleep study will provide the number of times the subject has apnea (temporary cessation of breathing) or hypopnea (slow or shallow breathing)
次要结局
- Pediatric sleep questionnaire (PSQ) after treatment(6 weeks after drug treatment started)
- Pediatric sleep questionnaire (PSQ) after placebo(6 weeks after placebo treatment started.)
- Pediatric sleep questionnaire (PSQ) at baseline(Start of study)