Verbesserung Der Schlafqualität Durch RePneu® Coils Zur Behandlung Des Fortgeschrittenen Lungenemphysems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment.
研究概览
简要总结
Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema.
Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after.
Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment.
Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Written consent
- •RePneu Coil treatment according to clinical criteria
排除标准
- •Pregnancy or nursing period
- •Participation in another clinical trial within the last 4 weeks
- •Incapable of giving consent
- •Known OSA (AHI>10)
研究组 & 干预措施
RePneum coils
Patients who needed lung volume reduction with RePneum coils
干预措施: Polysomnographic diagnostic (Other)
结局指标
主要结局
Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment.
时间窗: 3 times in one year
Sleep Efficiency is evaluated by the ratio of WASO (Time "wake after sleep onset") to Sleep Period Time (SPT).
次要结局
- Quality of life Questionnaire(3 times in one year)
研究者
Karl Josef Franke
Senior Physician
Helios Klinik Ambrock