Back to resultsTesting Cognitive Functions in Patients With COPD Using a Driving Simulator
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Driving simulator
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Driving simulator
Arm Description
Using the driving simulator for 30 min.
Outcomes
Primary Outcome Measures
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
Number of nil responses
Measuring the number of times the patients doesn't react to the number "2" on the screen
Response time
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
The number of times the car is off-road during the driving simulation
Secondary Outcome Measures
Number of patients with comorbidities
Patients with comorbidities will be registered
Lung function tests
Depression and anxiety
Using the Hospital Anxiety and Depression Scale
Cognitive functions
Using the Mini Mental State Examination and the Clock Drawing Test
Full Information
NCT ID
NCT02740673
First Posted
December 28, 2015
Last Updated
April 30, 2019
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02740673
Brief Title
Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
Official Title
Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Technical issues
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Driving simulator
Arm Type
Other
Arm Description
Using the driving simulator for 30 min.
Intervention Type
Device
Intervention Name(s)
Driving simulator
Intervention Description
Patients are asked to use a driving simulator to test their driving skills
Primary Outcome Measure Information:
Title
Standard deviation from the centre of the road
Description
Measuring how far from the centre of the road the patient has been driving in the driving simulation
Time Frame
During the 30 min. of driving in the simulator
Title
Number of nil responses
Description
Measuring the number of times the patients doesn't react to the number "2" on the screen
Time Frame
During the 30 min. of driving in the simulator
Title
Response time
Description
Measuring the mean amount of response time from the number "2" appears on the screen until the patient reacts
Time Frame
During the 30 min. of driving in the simulator
Title
Number of off-road events per hour
Description
The number of times the car is off-road during the driving simulation
Time Frame
During the 30 min. of driving in the simulator
Secondary Outcome Measure Information:
Title
Number of patients with comorbidities
Description
Patients with comorbidities will be registered
Time Frame
At enrolment
Title
Lung function tests
Time Frame
At enrolment
Title
Depression and anxiety
Description
Using the Hospital Anxiety and Depression Scale
Time Frame
At enrolment
Title
Cognitive functions
Description
Using the Mini Mental State Examination and the Clock Drawing Test
Time Frame
At enrolment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas S Prior, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
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