Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

NCT ID: NCT02125916

Last Updated: 2014-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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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

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Conditions

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Lung Diseases, Interstitial Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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COLD without long term oxygen therapy

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

Group Type EXPERIMENTAL

oxygen therapy

Intervention Type OTHER

COLD with long term oxygen therapy

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

Group Type EXPERIMENTAL

oxygen therapy

Intervention Type OTHER

ILD without long term oxygen therapy

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

Group Type EXPERIMENTAL

oxygen therapy

Intervention Type OTHER

Controls

Driving in the simulator one time without oxygen therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oxygen therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Skovhus Prior, MD

Role: PRINCIPAL_INVESTIGATOR

Department of pulmonology and allergology, Aarhus University Hospital, NBG

Ole Hilberg, Dr.med, MD

Role: STUDY_CHAIR

Department of pulmonology and allergology, Aarhus University Hospital, NBG

Locations

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Department of pulmonology and allergology, Aarhus University Hospital, NBG

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 26719805 (View on PubMed)

Other Identifiers

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Driving simulation COLD & ILD

Identifier Type: -

Identifier Source: org_study_id

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