Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Standard deviation from the centre of the road
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Driving simulator
Using the driving simulator for 30 min.
Intervention: Driving simulator (Device)
Outcomes
Primary Outcomes
Standard deviation from the centre of the road
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Cognitive functions(At enrolment)
- Depression and anxiety(At enrolment)
- Number of patients with comorbidities(At enrolment)
- Lung function tests(At enrolment)