Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

NCT02740673 | Withdrawn

• 1 other identifier: Driving simulator, COPD, v.2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Number of patients with comorbidities

  At enrolment

• Lung function tests

  At enrolment

• Depression and anxiety

  At enrolment

• Cognitive functions

  At enrolment

Study Arms (1)

Driving simulator

OTHER

Using the driving simulator for 30 min.

Device: Driving simulator

Interventions

Driving simulator DEVICE

Patients are asked to use a driving simulator to test their driving skills

Driving simulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas S Prior, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: April 15, 2016
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 2, 2019

Record last verified: 2018-05

Locations

DK (1)