Does Chronic Obstructive Lung Disease Influence the Cognitive Function

December 7, 2023 updated by: Kristina Kock Hansen, Sygehus Lillebaelt

Does Chronic Obstructive Lung Disease Influence the Cognitive Function: Assessment Using a Driving Simulator and Other Cognitive Tests

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 examines the cognitive skills of COPD patients, quantified by their ability to drive a vehicle and other cognitive test. Furthermore, we want to study the cognitive skills in COPD patients before and after they are diagnosed with and treated for obstructive sleep apnoea (OSA). The overall hypothesis is that chronic lung patients´ cognitive skills correlate with the severity of their disease. We expect that their ability to drive a vehicle drops in relation to the severity of the disease and to comorbidities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 simulator is being used. The subjects are placed in front of a computer monitor which simulates a horizon on the middle of the screen, and a road that appears in the bottom half of the screen. The subjects are encouraged to keep the virtual vehicle on the road, using a steering wheel in front of them. Simultaneous, they are required to keep focus on both sides of the screen where a line of numbers is frequently changing. Every time the number 2 occurs, the subjects must press a button on the steering wheel.

The subjects´ overall ability to control the driving simulator is being expressed by the standard deviation (sd) of distance of the car´s centre to the centre of the road and the number of off-road events. Relevant cognitive measurements, such as reaction speed and ability to split attention, are quantified by the reaction speed to the occurrence of the number 2. The reason for this is that the software of the simulator measures the mean reaction time from the number have occurred until the correct button is pressed, and the number of nil-responses, where the number 2 is not detected.

Every participating subject will receive a 5 minutes testing period of the simulator followed by 30 minutes of applicable driving time.The other tests will be performed/collected just after the driving test.

Besides the driving simulator and tests (see sections below) following are obtained: 1) Lung function (FEV1, FVC and FEV1/FVC), 2) Arterial blood sample including PaO2, PaCO2 and carbonmonooxidhemoglobin (HbCO) (1.5 ml), 3) Smoking status and number of pack years, 4) Status of oxygen therapy, 5) Number of COPD exacerbations in the last year, 6) Comorbidities such as diabetes, metabolic diseases, cardiovascular diseases, kidney insufficiency, 7) Medicine, 8) Height and weight, 9) Level of education, 10) Degree of dyspnoea Medical research Council breathlessness scale (MRC-scale) and 11) Global initiative for chronic Obstructive Lung Disease (GOLD) classification of airflow limitation.

The blood samples will be analysed immediately after they are taken, and as a consequence no biobank will be established. The information will be gathered from the journals and from patient interview in connection with the trial. The information will be used in the assessment of possible reasons to COPD patients´ expected reduced cognitive skills.

The NOX T3TM (see section below) will be delivered in connection with the trial. If the patients are diagnosed with OSA they will shortly after receive standard treatment in the public Sleep Clinic at Vejle Hospital, if the patients accept. After 2-3 month of treatment, the patients will repeat all the tests and blood samples, except the cardiorespiratory monitoring.

To exclude that an improvement of skills is not due to the patients having learned how to improve the test, we will establish a control group. The control group must consist of COPD patients without OSA who must perform a retest like the patients with OSA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Vejle, Denmark, 7100
        • Sygehus Lillebaelt

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Doctor-diagnosed chronic obstructive lung disease (forced expiratory volume in the first second (FEV1) / forced expiratory vital capacity (FVC) <0.70).
  2. Severity of COPD - GOLD 3+4 (GOLD 2019 classification).
  3. No exacerbations in the last 6 weeks (aggravation of the respiratory symptoms compared with habitual state, which require treatment).
  4. Age ≥ 40 years and ≤ 75 years
  5. The patient must have driven a vehicle within the last 3 months.

Exclusion Criteria:

  1. Lacking the ability to operate the driving simulator (physical deformities or lack of comprehensive skills to understand instruction of operating the simulator).
  2. No valid driver´s license.
  3. Do not read and understand Danish.
  4. Known obstructive sleep apnoea (OSA).
  5. Alcohol consumption (>21 units per week for men, >14 units per week for women).
  6. Consumption of alcohol and/or narcotics within the last 24 hours.
  7. Uncorrected sight- or hearing reduction.
  8. 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.

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention arm
Other: driving simulator
For this study a driving simulator is being used which is an internationally approved method. Besides the driving simulator following tests are done: COPD Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), Montreal Cognitive Assessment (MoCA), a clock drawing test and a continuous reaction time test (CRT). A CardioRespiratory Monitor (CRM), NOX T3TM, is used to measure if the patients have moderate to severe OSA. Furthermore, following tests are done: Epworth Sleepiness Scale (ESS).
Other Names:
  • continuous reaction time test (CRT)
  • cardiorespiratory monitor (CRM)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Standard deviation from center of the road and number of off-road events
Time Frame: 3 years
driving simulator
3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sygehus Lillebaelt

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danmarks Lungeforening
Chiesi Foundation
Overlæge Jørgen Werner Schous og hustru, Else-Marie Schou, født Wonge´s Fond

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19/44919

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on driving simulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings