Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

Not Applicable

Withdrawn

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: Driving simulator

• Registration Number: NCT02740673
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Status Verified: 2018-05
• Study Start: 2019-01
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Driving simulator	Driving simulator	Using the driving simulator for 30 min.

Primary Outcome Measures

Name	Time	Method
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 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
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 Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark