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【ChiCTR-TRC-10001136】手術治療對輕度阻塞性睡眠呼吸暫停綜合症兒童的認知功能之影響

基本信息
登记号

ChiCTR-TRC-10001136

试验状态

正在进行

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2010-12-21

临床申请受理号

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靶点

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适应症

Childhood obstructive sleep apnoea

试验通俗题目

手術治療對輕度阻塞性睡眠呼吸暫停綜合症兒童的認知功能之影響

试验专业题目

手術治療對輕度阻塞性睡眠呼吸暫停綜合症兒童的認知功能之影響\

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

Effect of adenotonsillectomy on behavioural problems in children with mild obstructive sleep apnoea

试验分类
试验类型

随机平行对照

试验分期

其它

随机化

Computer-generated code

盲法

Single-blind

试验项目经费来源

Departmental Fund

试验范围

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目标入组人数

100

实际入组人数

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第一例入组时间

2010-12-28

试验终止时间

1990-01-01

是否属于一致性

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入选标准

(i) Hong Kong Chinese prepubertal children aged between 6-11 years; (ii) Mild OSA confirmed by nocturnal PSG (obstructive apnoea hypopnoea index (OAHI) between 1 and 5) and parental report of habitual snoring (at least 3 nights per week); (iii) Tonsil size grading >=1; (iv) Written informed consent obtained from parents.;

排除标准

(i) Previous upper airway surgery. (ii) Diagnosed to have attention deficit hyperactivity disorder (ADHD) or other psychiatric behavioural problems. (iii) Craniofacial anomalies. (iv) Severe health problems that could be exacerbated by delayed treatment of OSA. (v) SpO2 nadir <90% in nocturnal PSG. (vi) Receiving any forms of treatment for OSA. (vii) Receiving any medications for allergic rhinitis including nasal corticosteroids and antihistamines within 6 weeks from baseline PSG. (viii) Parental report that child has reached menarche (female participants). (ix) Refusal of the surgical procedures. (x) Obese children, defined as having a BMI of >=95th percentile (corresponding to a z score of 1.645) of the local reference.;

研究者信息
研究负责人姓名
试验机构

香港中文大學醫學院兒科學系

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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