Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Pulmonary Disease, Chronic Obstructive
- 发起方
- Aarhus University Hospital
- 试验地点
- 1
- 主要终点
- Standard deviation from the centre of the road
- 状态
- 撤回
- 最后更新
- 7年前
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.
研究者
入排标准
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
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)