Aufmerksamkeitstest Mittels Fahrsimulation Bei Normalpersonen Und Patienten Mit Obstruktivem Schlafapnoesyndrom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Standard deviations
研究概览
简要总结
Driving simulator programmes are used under a wide range of conditions, and a correlation of driving performance and real accident risks in patients with obstructive sleep apnoea syndrome(OSAS)could be shown. The most frequently used driving simulator is the Divided Attention Steering Simulator (DASS) of Stowood Scientific Instruments Ltd. (SSI). Until today there are no reference levels with regards to sex and age in existence. To define the boundaries of normality age and sex reference values are to be generated and compared to values of patients with OSAS.
50 male and 50 female healthy subjects (10 of each age decade between 20 and 70 years) will perform the DASS for 30 minutes. In the other arm 100 OSAS Patients will perform the test as well. A better differentiation of pathologic driving performance and response times of OSAS patients should be possible with new reference levels.
详细描述
The DASS programme records several data, including mean and absloute errors and standard deviations from centre and curve.
Additionally the response time to a randomly appearing target number is recorded (divided attention).
The standard deviation (curve) is the difference between the steering angle and the road angle. Standard deviation (centre) is the standard deviation of the centre of the car from the centre of the road.
Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.
The secondary task of the divided attention test is to respond to a randomly appearing target number at the sides of the monitor while trying to keep the car in the centre of the road.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •capability of giving consent
- •ESS (Epworth Sleepiness scale) score less than 9
- •Holding a driving license
- •diagnostic OSAS
- •capability of giving consent
- •Holding a driving licence
排除标准
- •Healthy subjects
- •suspected OSAS, any observed sleep disorders or snoring
- •acute cardial, pulmonal oder neurological disease
- •Patients - acute cardial, pulmonal oder neurological disease
结局指标
主要结局
Standard deviations
时间窗: 30 minutes
Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.
次要结局
- Reaction time(30 min)
研究者
Georg Nilius
Head of pneumological department of Helios Klinik Hagen Ambrock
Helios Klinik Ambrock