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Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

Primary Purpose

Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
oxygen therapy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lung Diseases, Interstitial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of pulmonology and allergology, Aarhus University Hospital, NBG

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

COLD without long term oxygen therapy

COLD with long term oxygen therapy

ILD without long term oxygen therapy

Controls

Arm Description

Driving in the simulator two times, one time with and one time without oxygen therapy

Driving in the simulator two times, one time with and one time without oxygen therapy

Driving in the simulator two times, one time with and one time without oxygen therapy

Driving in the simulator one time without oxygen therapy

Outcomes

Primary Outcome Measures

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
Number of nil responses
Measuring the number of times the patients doesn't react to the number "2" on the screen
Response time
Measuring the mean amount of response time from the number "2" appears on the screen until the patient reacts
Number of off-road events per hour
The number of times the car is off-road during the driving simulation

Secondary Outcome Measures

Full Information

First Posted
April 23, 2014
Last Updated
September 11, 2014
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02125916
Brief Title
Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients
Official Title
Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COLD without long term oxygen therapy
Arm Type
Experimental
Arm Description
Driving in the simulator two times, one time with and one time without oxygen therapy
Arm Title
COLD with long term oxygen therapy
Arm Type
Experimental
Arm Description
Driving in the simulator two times, one time with and one time without oxygen therapy
Arm Title
ILD without long term oxygen therapy
Arm Type
Experimental
Arm Description
Driving in the simulator two times, one time with and one time without oxygen therapy
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Driving in the simulator one time without oxygen therapy
Intervention Type
Other
Intervention Name(s)
oxygen therapy
Primary Outcome Measure Information:
Title
Standard deviation from the centre of the road
Description
Measuring how far from the centre of the road the patient has been driving in the driving simulation
Time Frame
During the 45 min. of driving in the simulator
Title
Number of nil responses
Description
Measuring the number of times the patients doesn't react to the number "2" on the screen
Time Frame
During the 45 min. of driving in the simulator
Title
Response time
Description
Measuring the mean amount of response time from the number "2" appears on the screen until the patient reacts
Time Frame
During the 45 min. of driving in the simulator
Title
Number of off-road events per hour
Description
The number of times the car is off-road during the driving simulation
Time Frame
During the 45 min. of driving in the simulator

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Skovhus Prior, MD
Organizational Affiliation
Department of pulmonology and allergology, Aarhus University Hospital, NBG
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ole Hilberg, Dr.med, MD
Organizational Affiliation
Department of pulmonology and allergology, Aarhus University Hospital, NBG
Official's Role
Study Chair
Facility Information:
Facility Name
Department of pulmonology and allergology, Aarhus University Hospital, NBG
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26719805
Citation
Skovhus Prior T, Troelsen T, Hilberg O. Driving performance in patients with chronic obstructive lung disease, interstitial lung disease and healthy controls: a crossover intervention study. BMJ Open Respir Res. 2015 Dec 17;2(1):e000092. doi: 10.1136/bmjresp-2015-000092. eCollection 2015.
Results Reference
derived

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Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

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