Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

Study Overview
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Brief Summary
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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.

Official Title
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Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Driving simulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Driving simulator<br>Using the driving simulator for 30 min. | Device: Driving simulator<br>* Patients are asked to use a driving simulator to test their driving skills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation from the centre of the road | Measuring how far from the centre of the road the patient has been driving in the driving simulation | During the 30 min. of driving in the simulator | 
| Number of nil responses | Measuring the number of times the patients doesn't react to the number 2 on the screen | During the 30 min. of driving in the simulator | 
| Response time | Measuring the mean amount of response time from the number 2 appears on the screen until the patient reacts | During the 30 min. of driving in the simulator | 
| Number of off-road events per hour | The number of times the car is off-road during the driving simulation | During the 30 min. of driving in the simulator | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with comorbidities | Patients with comorbidities will be registered | At enrolment | 
| Lung function tests |  | At enrolment | 
| Depression and anxiety | Using the Hospital Anxiety and Depression Scale | At enrolment | 
| Cognitive functions | Using the Mini Mental State Examination and the Clock Drawing Test | At enrolment |