Lung Diseases, InterstitialNCT02125916
Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients
A study testing oxygen therapy in people with Lung Diseases, Interstitial and Pulmonary Disease, Chronic Obstructive, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- comorbidity which decreases cognitive function
- comorbidity which decreases concentration
- physical comorbidity which makes it impossible to complete the test
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of pulmonology and allergology, Aarhus University Hospital, NBG
Aarhus, 8000
About this study
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.
- Being tested
- oxygen therapy
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen therapyOther
| Study group | Role | What they receive |
|---|---|---|
| COLD without long term oxygen therapy | Experimental | Driving in the simulator two times, one time with and one time without oxygen therapy Receives: 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 Receives: 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 Receives: Other: oxygen therapy |
| Controls | No intervention | Driving in the simulator one time without oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: During the 45 min. of driving in the simulator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Skovhus Prior, MD, Principal investigator, Department of pulmonology and allergology, Aarhus University Hospital, NBGOle Hilberg, Dr.med, MD, Study chair, Department of pulmonology and allergology, Aarhus University Hospital, NBG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125916
- Sponsor's protocol ID
- Driving simulation COLD & ILD
- Status last verified
- Sep 2014
- First submitted
- 23 Apr 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Publications
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.
PubMed 26719805
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients
- ClinicalTrials.gov ID
- NCT02125916
- Acronym / sponsor ID
- Driving simulation COLD & ILD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COLD without long term oxygen therapy | Experimental | Other: oxygen therapyDriving in the simulator two times, one time with and one time without oxygen therapy |
| COLD with long term oxygen therapy | Experimental | Other: oxygen therapyDriving in the simulator two times, one time with and one time without oxygen therapy |
| ILD without long term oxygen therapy | Experimental | Other: oxygen therapyDriving in the simulator two times, one time with and one time without oxygen therapy |
| Controls | No intervention | –Driving in the simulator one time without oxygen therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- comorbidity which decreases cognitive function
- comorbidity which decreases concentration
- physical comorbidity which makes it impossible to complete the test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen therapy | Other | COLD with long term oxygen therapy, COLD without long term oxygen therapy, ILD without long term oxygen therapy |
Primary outcome
Standard deviation from the centre of the road
Time frame: 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
Time frame: 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
Response time
Time frame: 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
Number of off-road events per hour
Time frame: During the 45 min. of driving in the simulator
The number of times the car is off-road during the driving simulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Derived from this study: PubMed 26719805Skovhus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Skovhus Prior, MD principal investigator
Department of pulmonology and allergology, Aarhus University Hospital, NBG
Ole Hilberg, Dr.med, MD study chair
Department of pulmonology and allergology, Aarhus University Hospital, NBG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxygen therapy in people with Lung Diseases, Interstitial and Pulmonary Disease, Chronic Obstructive, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard deviation from the centre of the road (time frame: During the 45 min. of driving in the simulator). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02125916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.