Does Chronic Obstructive Lung Disease Influence the Cognitive Function

NCT04458038 | Unknown DMC

• 1 other identifier: 19/44919
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Standard deviation from center of the road and number of off-road events

  driving simulator

  3 years

Study Arms (1)

intervention arm

EXPERIMENTAL

Other: driving simulator

Interventions

driving simulator 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).

Also known as: continuous reaction time test (CRT), cardiorespiratory monitor (CRM)

intervention arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sygehus Lillebaelt: lead
• Chiesi Foundation: collaborator
• Overlæge Jørgen Werner Schous og hustru, Else-Marie Schou, født Wonge´s Fond: collaborator
• Danmarks Lungeforening: collaborator

Study Sites (1)

Sygehus Lillebaelt

Vejle, 7100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 39673053 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science in Health Science

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: December 7, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)