Does Chronic Obstructive Lung Disease Influence the Cognitive Function

NCT ID: NCT04458038

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2023-12-31

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 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.

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

intervention arm

Group Type: EXPERIMENTAL

driving simulator

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

continuous reaction time test (CRT); cardiorespiratory monitor (CRM)

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Foundation

UNKNOWN

Sponsor Role: collaborator

Overlæge Jørgen Werner Schous og hustru, Else-Marie Schou, født Wonge´s Fond

UNKNOWN

Sponsor Role: collaborator

Danmarks Lungeforening

OTHER

Sponsor Role: collaborator

Sygehus Lillebaelt

OTHER

Sponsor Role: lead

Responsible Party

Kristina Kock Hansen

Master of Science in Health Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sygehus Lillebaelt

Vejle, , Denmark

Countries

Denmark

References

Hansen KK, Lokke A, Jensen HI, Gantzhorn EK, Farver-Vestergaard I, Hilberg O. Examining the impact of obstructive sleep apnea on cognitive function in severe COPD. Sleep Breath. 2024 Dec 14;29(1):59. doi: 10.1007/s11325-024-03228-5.

Reference Type: DERIVED

PMID: 39673053 (View on PubMed)

Other Identifiers

19/44919

Identifier Type: -

Identifier Source: org_study_id