NCT02405624Unknown4 期
Efficacy of Continuous Positive Airway Pressure of Treatment of Hypernasality of Children With Infantile Pompe Disease
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- decrease in hypernasality
研究概览
简要总结
Patients with infantile onset Pompe disease will be trained with continuous positive airway pressure to see if hypernasality can be improved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •confirm as Pompe disease
- •Age 4 and can speak 2-words sentence by order
- •mild to severe hypernasality
- •have regular speech therapy for 8 weeks or longer
排除标准
- •(1）hearing loss （2）congenital pharyngeal or laryngeal structure anomalies including cleft palate （3）cerebral palsy （4）recent otitis media effusion （5）very severe hypernasality （6）use non-invasive ventilator
结局指标
主要结局
decrease in hypernasality
时间窗: 6 months
score hypernasality degree and compare
次要结局
- increase in speech intelligibility(6 months)
研究者
National Taiwan University Hospital
MD, PhD
National Taiwan University Hospital
研究点 (2)
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