Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125916
• Other study ID #: Driving simulation COLD & ILD
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: September 11, 2014
• Start date: July 2014

Study information

• Verified date: September 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• oxygen therapy

Locations

Country	Name	City	State
Denmark	Department of pulmonology and allergology, Aarhus University Hospital, NBG	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard deviation from the centre of the road	Measuring how far from the centre of the road the patient has been driving in the driving simulation	During the 45 min. of driving in the simulator	No
Primary	Number of nil responses	Measuring the number of times the patients doesn't react to the number "2" on the screen	During the 45 min. of driving in the simulator	No
Primary	Response time	Measuring the mean amount of response time from the number "2" appears on the screen until the patient reacts	During the 45 min. of driving in the simulator	No
Primary	Number of off-road events per hour	The number of times the car is off-road during the driving simulation	During the 45 min. of driving in the simulator	No