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Completed

NCT Number: NCT02125916

Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

The objective is to study the cognitive functions in patients with chronic obstructive lung disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy controls. The cognitive functions are tested with and without oxygen therapy to clarify the effect of oxygen therapy. Driving simulations is used to test the cognitive functions.

The hypothesis is that patients with chronic lung disease have decreased cognitive functions and that oxygen therapy will increase their cognitive functions.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of pulmonology and allergology, Aarhus University Hospital, NBG

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COLD with forced expiratory volume at one second (FEV1) <50%, without long term oxygen therapy
  • COLD with FEV1 <50%, with long term oxygen therapy
  • ILD with diffusion capacity of lung for carbon monoxide (DLCO) < 50%, without long term oxygen therapy

Exclusion criteria

  • comorbidity which decreases cognitive function
  • comorbidity which decreases concentration
  • physical comorbidity which makes it impossible to complete the test

Treatment and study plan

Oxygen therapy

Other

Primary outcomes

  1. Standard deviation from the centre of the road

    Time frame: During the 45 min. of driving in the simulator

    Measuring how far from the centre of the road the patient has been driving in the driving simulation

  2. Number of nil responses

    Time frame: During the 45 min. of driving in the simulator

    Measuring the number of times the patients doesn't react to the number "2" on the screen

  3. Response time

    Time frame: During the 45 min. of driving in the simulator

    Measuring the mean amount of response time from the number "2" appears on the screen until the patient reacts

  4. Number of off-road events per hour

    Time frame: During the 45 min. of driving in the simulator

    The number of times the car is off-road during the driving simulation

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
First posted
Apr 29, 2014
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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