CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Adherence to CPAP usage
研究概览
简要总结
Apoplexy patients with OSA are often not receiving a CPAP therapy due to generally poor acceptance and adherence. There is a great potential to significantly improve the treatment and care of these patients in a time economic way by telemonitoring the therapy in home environment.
This study is planned to prove that telephone consultancy and motivation in times of recorded decreasing CPAP therapy usage can improve adherence, neurological function and quality of life.
详细描述
Eligible patients with confirmed OSA from neurological rehab department of Helios Clinic Hagen Ambrock are asked to join the study. They will be randomly assigned to one of two arms [CPAP with Telemonitoring (MTM) or without Telemonitoring (OTM)] for 6 months of home treatment after hospital discharge. The MTM arm will receive supporting phone calls when the monitored usage time decreases.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •s/p ACM (Arteria Cerebri Media Insult)
- •Diagnosed OSA AHI >15/h
- •Barthel Index item 8 > 5 points (or home assistance)
- •Life expectancy >6 month
- •Capable of giving consent
排除标准
- •Already existing ventilatory support (CPAP, NIV etc)
- •Central AI >50% baseline
- •Central AI >5/h under CPAP therapy
- •Drug abuse
- •Pregnant or nursing women
- •Participation in another clinical trial last 4 weeks
研究组 & 干预措施
Unattended CPAP therapy
Therapy data will be examined by reading out the CPAP device after 6 months. Patients can obtain help on own request, corresponding to the standard CPAP prescription routine.
干预措施: CPAP therapy (Device)
Telemonitoring and support
CPAP device therapy data will be downloaded by the study site via GSM modules once a week. In case of poor therapy adherence (defined by a minimum average usage of 3h/night over the week) a contact call will be initiated to motivate patients or solve problems identified by telemonitoring. If active home intervention is required, the study site will inform the healthcare provider to visit the patient in a timely manner.
干预措施: CPAP therapy (Device)
Telemonitoring and support
CPAP device therapy data will be downloaded by the study site via GSM modules once a week. In case of poor therapy adherence (defined by a minimum average usage of 3h/night over the week) a contact call will be initiated to motivate patients or solve problems identified by telemonitoring. If active home intervention is required, the study site will inform the healthcare provider to visit the patient in a timely manner.
干预措施: Support (Other)
结局指标
主要结局
Adherence to CPAP usage
时间窗: 6 months
CPAP device usage time will be readout and compared.
次要结局
- Quality of life(6 months)
研究者
Georg Nilius
Head of Pneumology Department of Helios Clinic Hagen
Institut für Pneumologie Hagen Ambrock eV