Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

Not Applicable

Completed

• Conditions: Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive
• Interventions: Other: oxygen therapy

• Registration Number: NCT02125916
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Study Start: 2014-07
• Primary Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
COLD without long term oxygen therapy	oxygen therapy	Driving in the simulator two times, one time with and one time without oxygen therapy
ILD without long term oxygen therapy	oxygen therapy	Driving in the simulator two times, one time with and one time without oxygen therapy
COLD with long term oxygen therapy	oxygen therapy	Driving in the simulator two times, one time with and one time without oxygen therapy

Primary Outcome Measures

Name	Time	Method
Response time	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
Standard deviation from the centre of the road	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
Number of nil responses	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
Number of off-road events per hour	During the 45 min. of driving in the simulator	The number of times the car is off-road during the driving simulation

Trial Locations

Locations (1)

Department of pulmonology and allergology, Aarhus University Hospital, NBG; 🇩🇰 Aarhus, Denmark