<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04458038</url>
  </required_header>
  <id_info>
    <org_study_id>19/44919</org_study_id>
    <nct_id>NCT04458038</nct_id>
  </id_info>
  <brief_title>Does Chronic Obstructive Lung Disease Influence the Cognitive Function</brief_title>
  <official_title>Does Chronic Obstructive Lung Disease Influence the Cognitive Function: Assessment Using a Driving Simulator and Other Cognitive Tests</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sygehus Lillebaelt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chiesi Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Overlæge Jørgen Werner Schous og hustru, Else-Marie Schou, født Wonge´s Fond</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sygehus Lillebaelt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have documented impaired cognitive function in patients with COPD. The possible&#xD;
      reasons for this and correlation to the severity of the disease are not well described. This&#xD;
      explorative study examines the cognitive skills of COPD patients, quantified by their ability&#xD;
      to drive a vehicle and other cognitive test. Furthermore, we want to study the cognitive&#xD;
      skills in COPD patients before and after they are diagnosed with and treated for obstructive&#xD;
      sleep apnoea (OSA). The overall hypothesis is that chronic lung patients´ cognitive skills&#xD;
      correlate with the severity of their disease. We expect that their ability to drive a vehicle&#xD;
      drops in relation to the severity of the disease and to comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      200 COPD patients recruited from the outpatient clinic at the Department of Respiratory&#xD;
      Diseases at Vejle Hospital. Approximately 2600 COPD patients are treated in Vejle.&#xD;
&#xD;
      For this study a driving simulator is being used. The subjects are placed in front of a&#xD;
      computer monitor which simulates a horizon on the middle of the screen, and a road that&#xD;
      appears in the bottom half of the screen. The subjects are encouraged to keep the virtual&#xD;
      vehicle on the road, using a steering wheel in front of them. Simultaneous, they are required&#xD;
      to keep focus on both sides of the screen where a line of numbers is frequently changing.&#xD;
      Every time the number 2 occurs, the subjects must press a button on the steering wheel.&#xD;
&#xD;
      The subjects´ overall ability to control the driving simulator is being expressed by the&#xD;
      standard deviation (sd) of distance of the car´s centre to the centre of the road and the&#xD;
      number of off-road events. Relevant cognitive measurements, such as reaction speed and&#xD;
      ability to split attention, are quantified by the reaction speed to the occurrence of the&#xD;
      number 2. The reason for this is that the software of the simulator measures the mean&#xD;
      reaction time from the number have occurred until the correct button is pressed, and the&#xD;
      number of nil-responses, where the number 2 is not detected.&#xD;
&#xD;
      Every participating subject will receive a 5 minutes testing period of the simulator followed&#xD;
      by 30 minutes of applicable driving time.The other tests will be performed/collected just&#xD;
      after the driving test.&#xD;
&#xD;
      Besides the driving simulator and tests (see sections below) following are obtained: 1) Lung&#xD;
      function (FEV1, FVC and FEV1/FVC), 2) Arterial blood sample including PaO2, PaCO2 and&#xD;
      carbonmonooxidhemoglobin (HbCO) (1.5 ml), 3) Smoking status and number of pack years, 4)&#xD;
      Status of oxygen therapy, 5) Number of COPD exacerbations in the last year, 6) Comorbidities&#xD;
      such as diabetes, metabolic diseases, cardiovascular diseases, kidney insufficiency, 7)&#xD;
      Medicine, 8) Height and weight, 9) Level of education, 10) Degree of dyspnoea Medical&#xD;
      research Council breathlessness scale (MRC-scale) and 11) Global initiative for chronic&#xD;
      Obstructive Lung Disease (GOLD) classification of airflow limitation.&#xD;
&#xD;
      The blood samples will be analysed immediately after they are taken, and as a consequence no&#xD;
      biobank will be established. The information will be gathered from the journals and from&#xD;
      patient interview in connection with the trial. The information will be used in the&#xD;
      assessment of possible reasons to COPD patients´ expected reduced cognitive skills.&#xD;
&#xD;
      The NOX T3TM (see section below) will be delivered in connection with the trial. If the&#xD;
      patients are diagnosed with OSA they will shortly after receive standard treatment in the&#xD;
      public Sleep Clinic at Vejle Hospital, if the patients accept. After 2-3 month of treatment,&#xD;
      the patients will repeat all the tests and blood samples, except the cardiorespiratory&#xD;
      monitoring.&#xD;
&#xD;
      To exclude that an improvement of skills is not due to the patients having learned how to&#xD;
      improve the test, we will establish a control group. The control group must consist of COPD&#xD;
      patients without OSA who must perform a retest like the patients with OSA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Standard deviation from center of the road and number of off-road events</measure>
    <time_frame>3 years</time_frame>
    <description>driving simulator</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>driving simulator</intervention_name>
    <description>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).</description>
    <arm_group_label>intervention arm</arm_group_label>
    <other_name>continuous reaction time test (CRT)</other_name>
    <other_name>cardiorespiratory monitor (CRM)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Doctor-diagnosed chronic obstructive lung disease (forced expiratory volume in the&#xD;
             first second (FEV1) / forced expiratory vital capacity (FVC) &lt;0.70).&#xD;
&#xD;
          2. Severity of COPD - GOLD 3+4 (GOLD 2019 classification).&#xD;
&#xD;
          3. No exacerbations in the last 6 weeks (aggravation of the respiratory symptoms compared&#xD;
             with habitual state, which require treatment).&#xD;
&#xD;
          4. Age ≥ 40 years and ≤ 75 years&#xD;
&#xD;
          5. The patient must have driven a vehicle within the last 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lacking the ability to operate the driving simulator (physical deformities or lack of&#xD;
             comprehensive skills to understand instruction of operating the simulator).&#xD;
&#xD;
          2. No valid driver´s license.&#xD;
&#xD;
          3. Do not read and understand Danish.&#xD;
&#xD;
          4. Known obstructive sleep apnoea (OSA).&#xD;
&#xD;
          5. Alcohol consumption (&gt;21 units per week for men, &gt;14 units per week for women).&#xD;
&#xD;
          6. Consumption of alcohol and/or narcotics within the last 24 hours.&#xD;
&#xD;
          7. Uncorrected sight- or hearing reduction.&#xD;
&#xD;
          8. Unstable ischemic heart disease, uncontrolled hypertension or diabetes, left sided&#xD;
             heart failure, serious neurologic conditions, cancer, phlebitis, severe psychiatric&#xD;
             diseases, uncontrolled thyroid disease or former apoplexy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sygehus Lillebaelt</investigator_affiliation>
    <investigator_full_name>Kristina Kock Hansen</investigator_full_name>
    <investigator_title>Master of Science in Health Science</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04458038
org study id: 19/44919
nct id: NCT04458038
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Standard deviation from center of the road and number of off-road events
time frame: 3 years
description: driving simulator
arm group label: intervention arm
arm group type: Experimental
intervention type: Other
intervention name: driving simulator
description: 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).
arm group label: intervention arm
other name: continuous reaction time test (CRT)
other name: cardiorespiratory monitor (CRM)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Sygehus Lillebaelt
investigator full name: Kristina Kock Hansen
investigator title: Master of Science in Health Science
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No