Testing Cognitive Functions in Patients With COPD Using a Driving Simulator

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02740673
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Device: Driving simulator	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
• Anticipated Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

Secondary Outcome Measures

1. Number of patients with comorbidities [At enrolment]

   Patients with comorbidities will be registered

2. Lung function tests [At enrolment]

3. Depression and anxiety [At enrolment]

   Using the Hospital Anxiety and Depression Scale

4. Cognitive functions [At enrolment]

   Using the Mini Mental State Examination and the Clock Drawing Test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8000

Sponsors and Collaborators

• Aarhus University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT02740673
• Other Study ID Numbers: Driving simulator, COPD, v.2
• First Posted: Apr 15, 2016
• Last Update Posted: May 2, 2019
• Last Verified: May 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of May 2, 2019