Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

April 30, 2019 updated by: Aarhus University Hospital
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Driving simulator
Using the driving simulator for 30 min.
Device: Driving simulator
Patients are asked to use a driving simulator to test their driving skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the 30 min. of driving in the simulator
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
During the 30 min. of driving in the simulator
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
During the 30 min. of driving in the simulator
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
During the 30 min. of driving in the simulator

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Investigators

  • Principal Investigator: Thomas S Prior, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Driving simulator, COPD, v.2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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