Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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.
Interventions
DEVICEDriving simulator
Patients are asked to use a driving simulator to test their driving skills
Sponsors
Aarhus University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of off-road events per hour | During the 30 min. of driving in the simulator | The number of times the car is off-road during the driving simulation |
| Standard deviation from the centre of the road | 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 nil responses | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with comorbidities | At enrolment | Patients with comorbidities will be registered |
| Lung function tests | At enrolment | — |
| Depression and anxiety | At enrolment | Using the Hospital Anxiety and Depression Scale |
| Cognitive functions | At enrolment | Using the Mini Mental State Examination and the Clock Drawing Test |
Countries
Denmark
Outcome results
None listed