Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Standard deviation from the centre of the road
研究概览
简要总结
Little is known about the causes and degree of cognitive dysfunction in patients with Chronic Obstructive Pulmonary Disease (COPD), especially their driving abilities. The purpose of the study is to examine the cognitive skills of patients with COPD by using a driving simulator and to examine correlations to factors that may predict cognitive dysfunction in these patients.
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
- •a diagnosis of COPD (Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 0,70)
- •no exacerbations within the last 6 weeks
- •valid driver's license and having driven a car within the last 3 months
排除标准
- •lacking the ability to use the driving simulator
- •no valid driver's license
- •alcohol abuse (> 21 units per week)
- •a known diagnosis of obstructive sleep apnea
- •uncorrected impaired vision or hearing
- •unstable ischemic heart disease, left-sided heart failure, severe neurologic diseases, cancer, severe peripheral vascular disease, severe psychiatric diseases, former apoplexia and uncontrolled hypertension, thyroid diseases or diabetes
研究组 & 干预措施
Driving simulator
Using the driving simulator for 30 min.
干预措施: Driving simulator (Device)
结局指标
主要结局
Standard deviation from the centre of the road
时间窗: During the 30 min. of driving in the simulator
Measuring how far from the centre of the road the patient has been driving in the driving simulation
Number of off-road events per hour
时间窗: During the 30 min. of driving in the simulator
The number of times the car is off-road during the driving simulation
Number of nil responses
时间窗: During the 30 min. of driving in the simulator
Measuring the number of times the patients doesn't react to the number "2" on the screen
Response time
时间窗: During the 30 min. of driving in the simulator
Measuring the mean amount of response time from the number "2" appears on the screen until the patient reacts
次要结局
- Cognitive functions(At enrolment)
- Depression and anxiety(At enrolment)
- Number of patients with comorbidities(At enrolment)
- Lung function tests(At enrolment)