ClinicalTrials.gg
Sign In
CompletedNCT03823677DRU-EMO-KUpdated May 17, 2022

Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia

An interventional study of Hypoxia in Hypoxia, Altitude, sponsored by Universitätsklinikum Köln. Completed at 1 site in Germany. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by Universitätsklinikum Köln · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2018, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Hypoxia, Altitude

Browse trials for

03

In context

Altitude Sickness

192 studies on the registry are indexed under Altitude Sickness; 45 are open to participants now.

This study's enrollment of 250 is above the median of 34 across 159 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

Universitätsklinikum Köln is the lead sponsor of 33 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Helathy

Exclusion criteria

Exclusion Criteria:

  • Ear problems
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
250 participants (actual)

Study arms

  • No intervention
    control group 15

    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

  • No intervention
    control group 30

    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

  • No intervention
    control group 60

    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

  • Experimental
    hypoxia 5000ft group 15

    Intervention: 15 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 5000ft group 30

    Intervention: 30 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 5000ft group 60

    Intervention: 60 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 8000ft group 15

    Intervention: 15 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 8000ft group 30

    Intervention: 30 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 8000ft group 60

    Intervention: 60 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 10000ft group 15

    Intervention: 15 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 10000ft group 30

    Intervention: 30 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 10000ft group 60

    Intervention: 60 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 15000ft group 15

    Intervention: 15 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 15000ft group 30

    Intervention: 30 minutes hypoxia

    Procedure: Hypoxia

  • Experimental
    hypoxia 15000ft group 60

    Intervention: 60 minutes hypoxia

    Procedure: Hypoxia

Interventions

  • ProcedureHypoxia

    hypoxia

06

What researchers measure

Primary outcomes

  1. Protein Expression before hypoxia

    proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics

    Time frame: Measurement immediately 1 minute before of hypoxia/experiment

  2. Protein Expression after hypoxia

    proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics

    Time frame: Measurement immediately and at termination (i.e., 1 minute after) of hypoxia/experiment

  3. Emotional assessment tears

    Emotional tears test

    Time frame: Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes

  4. 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.

    Time frame: Measurement in the pressure chamber after tears test (i.e. 10 minutes after start). duration 10 minutes

  5. 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,

    Time frame: Measurement in the pressure chamber after stroop test (i.e. 20 minutes after start). duration 10 minutes

07

Study locations

1 site
  • University Hospital of Cologne
    Cologne, North Rhine-Westphalia 50937, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Apr 2022, 45 months.

Of 58 non-industry interventional studies with no phase under Altitude Sickness, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 27. This study's 45 months is above that.

Counting every sponsor, half of 58 studies reached it within 11 months; a quarter within 2 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2019
First posted
Jan 30, 2019
StartActual
Jul 1, 2018
Primary completionActual
Apr 30, 2022
CompletionActual
Apr 30, 2022
Last update
May 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03823677
Lead sponsor
Universitätsklinikum Köln
Responsible party
Jochen Hinkelbein (Clinical Professor, Universitätsklinikum Köln) — Principal investigator
First posted
Jan 30, 2019
Start date
Jul 1, 2018
Primary completion
Apr 30, 2022
Completion
Apr 30, 2022
Last update
May 17, 2022

Study contacts

Jochen Hinkelbein
study chair · University Hospital of Cologne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Altitude Sickness →

Other studies from this sponsor

Universitätsklinikum Köln

Start the discussion