Untersuchung Der Übereinstimmung Der Ereigniserkennung Von "prismaLine" Geräten Mit Der Polysomnographie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- apnea- hypopnea- index (AHI)
研究概览
简要总结
Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP machines with manual scored polysomnography (PSG).
详细描述
The evaluation of residual sleep disordered breathing (SDB) in sleep apnea (SA) after initiation of continuous positive airway pressure (CPAP) therapy is important to verify the therapeutic success. In clinical practice, the internal records of CPAP devices are utilized to determine the therapeutic success, during either medical consultations or telemetric observation.
This study was designed to evaluate the quality of SDB Event Indices (EI), which are recorded by the CPAP device (Prisma, Löwenstein Medical Technology).
The detected events of a manual scored polysomnography (PSG) in the sleep laboratory will be compared with the simultaneously recorded events of the CPAP device.
This shall lead to recommendations regarding the situations, and in which degree the event detection of the CPAP devices may be meaningful to determine the therapeutic success of home sleep apnea therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •PSG diagnostic not older than 3 month,
- •AHI>15, CPAP indication,
- •age >18,
- •nasal CPAP mask,
- •written informed consent
排除标准
- •CPAP contraindication,
- •participation in another clinical trial
结局指标
主要结局
apnea- hypopnea- index (AHI)
时间窗: up to 8 hours
Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log
次要结局
- central and obstructive hypopnea index(up to 8 hours)
- hypopnea index relating to oxygen desaturation(up to 8 hours)
研究者
Georg Nilius, PD DR med
medical director of pneumologic department
Institut für Pneumologie Hagen Ambrock eV