Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 10
- 主要终点
- Pulmonary static hyperinflation assessed by residual volume
研究概览
简要总结
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc...). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.
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
- 14 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •one of the 56 first patients of HOME-CARE SIMEOX study
- •same criteria as HOME-CARE SIMEOX study
排除标准
- •same criteria as HOME-CARE SIMEOX study
结局指标
主要结局
Pulmonary static hyperinflation assessed by residual volume
时间窗: Change from baseline at 3 months
Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.
次要结局
- Use assessed by the duration of use of SIMEOX® device(During 3 months of use)
- Inspiratory capacity(Change from baseline at 3 months)
- Residual functional capacity (RFC)(Change from baseline at 3 months)
- Total lung capacity (TLC)(Change from baseline at 3 months)
