Pulmonary Disease, Chronic ObstructiveNCT02740673
Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
A study testing Driving simulator in people with Pulmonary Disease, Chronic Obstructive, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Driving simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2019to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Driving simulator
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving simulatorDevice
Patients are asked to use a driving simulator to test their driving skills
| Study group | Role | What they receive |
|---|---|---|
| Driving simulator | Other | Using the driving simulator for 30 min. Receives: Device: Driving simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: During the 30 min. of driving in the simulator
Secondary outcomes (4)
Number of patients with comorbidities
Patients with comorbidities will be registered
Measured: At enrolment
Lung function tests
Measured: At enrolment
Depression and anxiety
Using the Hospital Anxiety and Depression Scale
Measured: At enrolment
Cognitive functions
Using the Mini Mental State Examination and the Clock Drawing Test
Measured: At enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJan 2019 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas S Prior, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740673
- Sponsor's protocol ID
- Driving simulator, COPD, v.2
- Status last verified
- May 2018
- First submitted
- 28 Dec 2015
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
- ClinicalTrials.gov ID
- NCT02740673
- Acronym / sponsor ID
- Driving simulator, COPD, v.2
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Driving simulator | Other | Device: Driving simulatorUsing the driving simulator for 30 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving simulatorPatients are asked to use a driving simulator to test their driving skills | Device | Driving simulator |
Primary outcome
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
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
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
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
4 secondary outcomes
Number of patients with comorbidities
Time frame: At enrolment
Lung function tests
Time frame: At enrolment
Depression and anxiety
Time frame: At enrolment
Cognitive functions
Time frame: At enrolment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
Related trials for Pulmonary Disease, Chronic Obstructive
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruiting
High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease
Chronic Respiratory Disease, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Active, not recruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas S Prior, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving simulator in people with Pulmonary Disease, Chronic Obstructive, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard deviation from the centre of the road (time frame: During the 30 min. of driving in the simulator). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019; AzTrials last refreshed its copy on 4 Nov 2026.