NCT02125916

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

April 23, 2014

Last Update Submit

September 11, 2014

Conditions

Lung Diseases, InterstitialPulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

COLD without long term oxygen therapy

EXPERIMENTAL

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

Other: oxygen therapy

COLD with long term oxygen therapy

EXPERIMENTAL

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

Other: oxygen therapy

ILD without long term oxygen therapy

EXPERIMENTAL

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

Other: oxygen therapy

Controls

NO INTERVENTION

Driving in the simulator one time without oxygen therapy

Interventions

oxygen therapyOTHER
COLD with long term oxygen therapyCOLD without long term oxygen therapyILD without long term oxygen therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pulmonology and allergology, Aarhus University Hospital, NBG

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26719805DERIVED

MeSH Terms

Conditions

Lung Diseases, InterstitialPulmonary Disease, Chronic Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Thomas Skovhus Prior, MD

    Department of pulmonology and allergology, Aarhus University Hospital, NBG

    PRINCIPAL INVESTIGATOR

  • Ole Hilberg, Dr.med, MD

    Department of pulmonology and allergology, Aarhus University Hospital, NBG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 29, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

DK(1)