Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

NCT02740673 — Not applicable, Withdrawn, Aarhus University Hospital

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Registry	NCT02740673
Status	Withdrawn - Technical issues
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Sponsor	Aarhus University Hospital (Other)
Conditions	Pulmonary Disease, Chronic Obstructive
Interventions	Driving simulator (Device)
Dates	start 2019-01-01 (estimated), primary completion 2022-01-01 (estimated), completion 2022-01-01 (estimated), first posted 2016-04-15, last updated 2019-05-02
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Driving simulator	Other	Device: Driving simulator	Using the driving simulator for 30 min.

Driving simulator (Device): Patients are asked to use a driving simulator to test their driving skills

+Outcome measures

Primary outcomes

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
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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Aarhus University Hospital	Aarhus	Denmark

+Investigators

Thomas S Prior, MD, Principal investigator, Aarhus University Hospital