NCT05785637招募中不适用
Initiation of Polygraphy for Neuromuscular Disease Patients Under Non-invasive Mechanical Ventilation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Gradation of quality of recorded signals at home
研究概览
简要总结
The primary objective of the study is to evaluate the feasibility, the quality and the utility of a polygraphic control at home in order to appreciate the efficacy of the night time non-invasive ventilation (allowing to optimize the ventilator settings when the results are not satisfactory).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patient ≥ 18 years;
- •Patient with chronic respiratory insufficiency has just been posed non-invasive ventilation (NIV) in the hospital, according to the latest international recommendations ;
- •Affiliation to the social security scheme;
- •Patient has signed the informed consent form to participate to the study.
排除标准
- •Patient refusal;
- •Patient under guardianship;
- •Patient under AME scheme;
- •Patients living more than 40 km from reference center;
- •Patient depending on mechanical ventilation (more than 6 hours daily);
- •Rapidly or reversible evolutive neuro-myopathy (Amyotrophic lateral sclerosis, Guillain Barré syndrome, myasthenia).
结局指标
主要结局
Gradation of quality of recorded signals at home
时间窗: at day 1
Expressed in number of readable signals for which the readability will be expressed in % of record time.
次要结局
未报告次要终点
研究者
研究点 (1)
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