Hypoxia, AltitudeDRU-EMO-KNCT03823677
Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia
A study testing Hypoxia in people with Hypoxia, Altitude, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Altitude
- What is being tested?
- Hypoxia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 30 Apr 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Helathy
Who cannot join
- Ear problems
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.
Read the detailed description
This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.
15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.
- Conditions
- Hypoxia, Altitude
- Being tested
- Hypoxia
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxiaProcedure or surgery
hypoxia
| Study group | Role | What they receive |
|---|---|---|
| control group 15 | No intervention | Protein expression and emotional test 15 minutes normoxia Interventions: Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels Emotional tests (tears, stroop, mood) during the pressure chamber phase |
| control group 30 | No intervention | 30 minutes normoxia Interventions: Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels Emotional tests (tears, stroop, mood) during the pressure chamber phase |
| control group 60 | No intervention | 60 minutes normoxia Interventions: Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels Emotional tests (tears, stroop, mood) during the pressure chamber phase |
| hypoxia 5000ft group 15 | Experimental | Intervention: 15 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 5000ft group 30 | Experimental | Intervention: 30 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 5000ft group 60 | Experimental | Intervention: 60 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 8000ft group 15 | Experimental | Intervention: 15 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 8000ft group 30 | Experimental | Intervention: 30 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 8000ft group 60 | Experimental | Intervention: 60 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 10000ft group 15 | Experimental | Intervention: 15 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 10000ft group 30 | Experimental | Intervention: 30 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 10000ft group 60 | Experimental | Intervention: 60 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 15000ft group 15 | Experimental | Intervention: 15 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 15000ft group 30 | Experimental | Intervention: 30 minutes hypoxia Receives: Procedure: Hypoxia |
| hypoxia 15000ft group 60 | Experimental | Intervention: 60 minutes hypoxia Receives: Procedure: Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Expression before hypoxia
proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics
Measured: Measurement immediately 1 minute before of hypoxia/experiment
Protein Expression after hypoxia
proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics
Measured: Measurement immediately and at termination (i.e., 1 minute after) of hypoxia/experiment
Emotional assessment tears
Emotional tears test
Measured: Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes
Emotional assessment
Emotional stroop test; Williams, J. M. G., Mathews, A., \& MacLeod, C. (1996). The emotional Stroop task and psychopathology. Psychological Bulletin, 120, 3-24.
Measured: Measurement in the pressure chamber after tears test (i.e. 10 minutes after start). duration 10 minutes
Emotional assessment mood
Emotional mood test, POMS mood score. Shukitt-Hale, B., Banderet, L.E., \& Lieberman, H.R. (1998). Elevation-dependent symptom, mood, and performance changes produced by exposure to hypobaric hypoxia, The International Journal of Aviation Psychology, 8, 319-334,
Measured: Measurement in the pressure chamber after stroop test (i.e. 20 minutes after start). duration 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Jul 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, AltitudeStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Hinkelbein, Universitätsklinikum Köln
- Investigators
- Jochen Hinkelbein, Study chair, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823677
- Sponsor's protocol ID
- DRU-EMO-KOELN
- Acronym
- DRU-EMO-K
- Status last verified
- May 2022
- First submitted
- 7 Jan 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia
- ClinicalTrials.gov ID
- NCT03823677
- Acronym / sponsor ID
- DRU-EMO-K / DRU-EMO-KOELN
- Conditions
- Hypoxia, Altitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Jan 2019 (actual)
- 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.
This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.
Detailed description
This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.
15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 15
- Model description
- 15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.
| Arm | Type | Receives |
|---|---|---|
| control group 15 | No intervention | –Protein expression and emotional test 15 minutes normoxia Interventions: Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels Emotional tests (tears, stroop, mood) during the pressure chamber phase |
| control group 30 | No intervention | –30 minutes normoxia Interventions: Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels Emotional tests (tears, stroop, mood) during the pressure chamber phase |
| control group 60 | No intervention | –60 minutes normoxia Interventions: Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels Emotional tests (tears, stroop, mood) during the pressure chamber phase |
| hypoxia 5000ft group 15 | Experimental | Procedure: HypoxiaIntervention: 15 minutes hypoxia |
| hypoxia 5000ft group 30 | Experimental | Procedure: HypoxiaIntervention: 30 minutes hypoxia |
| hypoxia 5000ft group 60 | Experimental | Procedure: HypoxiaIntervention: 60 minutes hypoxia |
| hypoxia 8000ft group 15 | Experimental | Procedure: HypoxiaIntervention: 15 minutes hypoxia |
| hypoxia 8000ft group 30 | Experimental | Procedure: HypoxiaIntervention: 30 minutes hypoxia |
| hypoxia 8000ft group 60 | Experimental | Procedure: HypoxiaIntervention: 60 minutes hypoxia |
| hypoxia 10000ft group 15 | Experimental | Procedure: HypoxiaIntervention: 15 minutes hypoxia |
| hypoxia 10000ft group 30 | Experimental | Procedure: HypoxiaIntervention: 30 minutes hypoxia |
| hypoxia 10000ft group 60 | Experimental | Procedure: HypoxiaIntervention: 60 minutes hypoxia |
| hypoxia 15000ft group 15 | Experimental | Procedure: HypoxiaIntervention: 15 minutes hypoxia |
| hypoxia 15000ft group 30 | Experimental | Procedure: HypoxiaIntervention: 30 minutes hypoxia |
| hypoxia 15000ft group 60 | Experimental | Procedure: HypoxiaIntervention: 60 minutes hypoxia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Helathy
Key exclusion criteria (1 listed)
- Ear problems
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 |
|---|---|---|
| Hypoxiahypoxia | Procedure or surgery | hypoxia 10000ft group 15, hypoxia 10000ft group 30, hypoxia 10000ft group 60, hypoxia 15000ft group 15, hypoxia 15000ft group 30, hypoxia 15000ft group 60, hypoxia 5000ft group 15, hypoxia 5000ft group 30, hypoxia 5000ft group 60, hypoxia 8000ft group 15, hypoxia 8000ft group 30, hypoxia 8000ft group 60 |
Primary outcome
Protein Expression before hypoxia
Time frame: Measurement immediately 1 minute before of hypoxia/experiment
proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics
Protein Expression after hypoxia
Time frame: Measurement immediately and at termination (i.e., 1 minute after) of hypoxia/experiment
proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics
Emotional assessment tears
Time frame: Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes
Emotional tears test
Emotional assessment
Time frame: Measurement in the pressure chamber after tears test (i.e. 10 minutes after start). duration 10 minutes
Emotional stroop test; Williams, J. M. G., Mathews, A., \& MacLeod, C. (1996). The emotional Stroop task and psychopathology. Psychological Bulletin, 120, 3-24.
Emotional assessment mood
Time frame: Measurement in the pressure chamber after stroop test (i.e. 20 minutes after start). duration 10 minutes
Emotional mood test, POMS mood score. Shukitt-Hale, B., Banderet, L.E., \& Lieberman, H.R. (1998). Elevation-dependent symptom, mood, and performance changes produced by exposure to hypobaric hypoxia, The International Journal of Aviation Psychology, 8, 319-334,
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 17 May 2022.
- Individual participant dataSharing planned: No
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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.
Jochen Hinkelbein study chair
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia in people with Hypoxia, Altitude, run by Universitätsklinikum Köln at 1 site in Germany.
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 1 inclusion and 1 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 17 May 2022. 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 Germany. 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?
Protein Expression before hypoxia (time frame: Measurement immediately 1 minute before of hypoxia/experiment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.