"New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)
研究概览
简要总结
The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •ALS diagnosis according to the criteria of El Escorial;
- •Clinical indication to NIV (nocturnal hypoventilation and respiratory muscle weakness confirmed according to the criteria normally accepted);
- •No respiratory infection within 3 months
- •Severe disability (ALS-FRS <31);
- •Age > 18 years;
- •The voluntary participation to the Study.
排除标准
- •- Previous episodes of pneumothorax;
- •Comorbid cardiac and / or renal important
- •Severe cognitive impairment;
- •Refusal of the patient at the time of Informed Consent.
研究组 & 干预措施
Home Group
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home
干预措施: Adaptation and training to Non Invasive Ventilation (NIV) (Other)
Outpatient Group
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic
干预措施: Adaptation and training to Non Invasive Ventilation (NIV) (Other)
结局指标
主要结局
Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)
时间窗: Baseline + after 2 and 4 months from the recruitment
The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month.
次要结局
未报告次要终点