NCT00394290已完成不适用
Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Down Syndrome patients with an Obstructive Sleep Apnea Syndrome
- •more than 18 years old
排除标准
- •predictable non-compliance of device
- •non-compensated cardiopathy
- •non-stable thyroxin treatment
- •non-stable diabetes
研究组 & 干预措施
PPC
Experimental
Night time device for positive pulmonary pressure
干预措施: Continuous Positive Pressure (Device)
结局指标
主要结局
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months)
时间窗: 0 and 3 months
次要结局
- Tolerability(0, 3 and 12 months)
研究者
研究点 (2)
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