Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Dextromethorphan urinary molar ratio
研究概览
简要总结
The purpose of this research study is to determine the effect of chronic nighttime low oxygen saturations on selected body systems (liver) that break down drugs in children with obstructive sleep apnea syndrome (OSAS).
详细描述
The purpose of this study is to determine the effect of chronic intermittent nocturnal hypoxia on selected hepatic drug-metabolizing enzyme systems in children with OSAS. The specific aims are to evaluate the activities of cytochrome P450 (CYP)1A2, N-acetyltransferase-2 (NAT-2), xanthine oxidase (XO)and CYP2D6 in children with OSAS and to determine the effect of OSAS treatment on the activities of these enzyme systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 4 to 16 years with suspected uncomplicated OSAS
排除标准
- •Children with complicated OSAS (craniofacial abnormalities, neuromuscular disorders)
- •Children who are receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO, CYP2D6 or CYP3A4 activity
- •Children who are exposed to second hand smoke for greater than 8 hours per day.
- •Children with hypersensitivity to caffeine or dextromethorphan
- •Children who are receiving corticosteroids or thyroid hormone
研究组 & 干预措施
1
Children with OSAS identified via sleep study
干预措施: Dextromethorphan (Drug)
1
Children with OSAS identified via sleep study
干预措施: Caffeine (Drug)
结局指标
主要结局
Dextromethorphan urinary molar ratio
时间窗: Pre and post T&A
Caffeine urinary molar ratio
时间窗: Pre and post T&A
次要结局
未报告次要终点