Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02740673
• Other study ID #: Driving simulator, COPD, v.2
• Status: Withdrawn
• Phase: N/A
• Start date: January 2019
• Est. completion date: January 2022

Study information

• Verified date: May 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number of patients with comorbidities	Patients with comorbidities will be registered	At enrolment
Secondary	Lung function tests		At enrolment
Secondary	Depression and anxiety	Using the Hospital Anxiety and Depression Scale	At enrolment
Secondary	Cognitive functions	Using the Mini Mental State Examination and the Clock Drawing Test	At enrolment