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Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia (DRU-EMO-K)

Primary Purpose

Hypoxia, Altitude

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypoxia
Sponsored by
Universitätsklinikum Köln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoxia, Altitude

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Helathy

Exclusion Criteria:

  • Ear problems

Sites / Locations

  • University Hospital of Cologne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

No Intervention

No Intervention

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

control group 15

control group 30

control 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

hypoxia 10000ft group 15

hypoxia 10000ft group 30

hypoxia 10000ft group 60

hypoxia 15000ft group 15

hypoxia 15000ft group 30

hypoxia 15000ft group 60

Arm Description

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

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

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

Intervention: 15 minutes hypoxia

Intervention: 30 minutes hypoxia

Intervention: 60 minutes hypoxia

Intervention: 15 minutes hypoxia

Intervention: 30 minutes hypoxia

Intervention: 60 minutes hypoxia

Intervention: 15 minutes hypoxia

Intervention: 30 minutes hypoxia

Intervention: 60 minutes hypoxia

Intervention: 15 minutes hypoxia

Intervention: 30 minutes hypoxia

Intervention: 60 minutes hypoxia

Outcomes

Primary Outcome Measures

Protein Expression before hypoxia
proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics
Protein Expression after hypoxia
proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics
Emotional assessment tears
Emotional tears test
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.
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,

Secondary Outcome Measures

Full Information

First Posted
January 7, 2019
Last Updated
May 16, 2022
Sponsor
Universitätsklinikum Köln
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1. Study Identification

Unique Protocol Identification Number
NCT03823677
Brief Title
Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia
Acronym
DRU-EMO-K
Official Title
Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Köln

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Altitude

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Participant
Masking Description
volunteers
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group 15
Arm Type
No Intervention
Arm Description
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
Arm Title
control group 30
Arm Type
No Intervention
Arm Description
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
Arm Title
control group 60
Arm Type
No Intervention
Arm Description
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
Arm Title
hypoxia 5000ft group 15
Arm Type
Experimental
Arm Description
Intervention: 15 minutes hypoxia
Arm Title
hypoxia 5000ft group 30
Arm Type
Experimental
Arm Description
Intervention: 30 minutes hypoxia
Arm Title
hypoxia 5000ft group 60
Arm Type
Experimental
Arm Description
Intervention: 60 minutes hypoxia
Arm Title
hypoxia 8000ft group 15
Arm Type
Experimental
Arm Description
Intervention: 15 minutes hypoxia
Arm Title
hypoxia 8000ft group 30
Arm Type
Experimental
Arm Description
Intervention: 30 minutes hypoxia
Arm Title
hypoxia 8000ft group 60
Arm Type
Experimental
Arm Description
Intervention: 60 minutes hypoxia
Arm Title
hypoxia 10000ft group 15
Arm Type
Experimental
Arm Description
Intervention: 15 minutes hypoxia
Arm Title
hypoxia 10000ft group 30
Arm Type
Experimental
Arm Description
Intervention: 30 minutes hypoxia
Arm Title
hypoxia 10000ft group 60
Arm Type
Experimental
Arm Description
Intervention: 60 minutes hypoxia
Arm Title
hypoxia 15000ft group 15
Arm Type
Experimental
Arm Description
Intervention: 15 minutes hypoxia
Arm Title
hypoxia 15000ft group 30
Arm Type
Experimental
Arm Description
Intervention: 30 minutes hypoxia
Arm Title
hypoxia 15000ft group 60
Arm Type
Experimental
Arm Description
Intervention: 60 minutes hypoxia
Intervention Type
Procedure
Intervention Name(s)
Hypoxia
Intervention Description
hypoxia
Primary Outcome Measure Information:
Title
Protein Expression before hypoxia
Description
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
Title
Protein Expression after hypoxia
Description
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
Title
Emotional assessment tears
Description
Emotional tears test
Time Frame
Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes
Title
Emotional assessment
Description
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
Title
Emotional assessment mood
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Helathy Exclusion Criteria: Ear problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Hinkelbein
Organizational Affiliation
University Hospital of Cologne
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia

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