Status:
UNKNOWN
Does Chronic Obstructive Lung Disease Influence the Cognitive Function
Lead Sponsor:
Sygehus Lillebaelt
Collaborating Sponsors:
Chiesi Foundation
Overlæge Jørgen Werner Schous og hustru, Else-Marie Schou, født Wonge´s Fond
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
Studies have documented impaired cognitive function in patients with COPD. The possible reasons for this and correlation to the severity of the disease are not well described. This explorative study e...
Detailed Description
200 COPD patients recruited from the outpatient clinic at the Department of Respiratory Diseases at Vejle Hospital. Approximately 2600 COPD patients are treated in Vejle. For this study a driving sim...
Eligibility Criteria
Inclusion
- Doctor-diagnosed chronic obstructive lung disease (forced expiratory volume in the first second (FEV1) / forced expiratory vital capacity (FVC) \<0.70).
- Severity of COPD - GOLD 3+4 (GOLD 2019 classification).
- No exacerbations in the last 6 weeks (aggravation of the respiratory symptoms compared with habitual state, which require treatment).
- Age ≥ 40 years and ≤ 75 years
- The patient must have driven a vehicle within the last 3 months.
Exclusion
- Lacking the ability to operate the driving simulator (physical deformities or lack of comprehensive skills to understand instruction of operating the simulator).
- No valid driver´s license.
- Do not read and understand Danish.
- Known obstructive sleep apnoea (OSA).
- Alcohol consumption (\>21 units per week for men, \>14 units per week for women).
- Consumption of alcohol and/or narcotics within the last 24 hours.
- Uncorrected sight- or hearing reduction.
- Unstable ischemic heart disease, uncontrolled hypertension or diabetes, left sided heart failure, serious neurologic conditions, cancer, phlebitis, severe psychiatric diseases, uncontrolled thyroid disease or former apoplexy.
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04458038
Start Date
December 7 2020
End Date
December 31 2023
Last Update
December 14 2023
Active Locations (1)
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1
Sygehus Lillebaelt
Vejle, Denmark, 7100