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

Sponsor

Universitätsklinikum Köln (Other)

Overall Status

Completed

CT.gov ID

NCT03823677

Collaborator

(none)

250

Enrollment

Location

Arms

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia, Altitude	Procedure: Hypoxia	N/A

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

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention 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.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 (Participant)

Masking Description:

volunteers

Primary Purpose:

Diagnostic

Official Title:

Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia

Actual Study Start Date :

Jul 1, 2018

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 hypoxia
Experimental: hypoxia 5000ft group 30 Intervention: 30 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 5000ft group 60 Intervention: 60 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 8000ft group 15 Intervention: 15 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 8000ft group 30 Intervention: 30 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 8000ft group 60 Intervention: 60 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 10000ft group 15 Intervention: 15 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 10000ft group 30 Intervention: 30 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 10000ft group 60 Intervention: 60 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 15000ft group 15 Intervention: 15 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 15000ft group 30 Intervention: 30 minutes hypoxia	Procedure: Hypoxia hypoxia
Experimental: hypoxia 15000ft group 60 Intervention: 60 minutes hypoxia	Procedure: Hypoxia hypoxia

Outcome Measures

Primary Outcome Measures

Protein Expression before hypoxia [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 [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 [Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes]
Emotional tears test
Emotional assessment [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 [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,

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Helathy

Exclusion Criteria:

Ear problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Cologne	Cologne	NRW	Germany	50937

Sponsors and Collaborators

Universitätsklinikum Köln

Investigators

Study Chair: Jochen Hinkelbein, University Hospital of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jochen Hinkelbein, Clinical Professor, Universitätsklinikum Köln

ClinicalTrials.gov Identifier:

NCT03823677

Other Study ID Numbers:

DRU-EMO-KOELN

First Posted:

Jan 30, 2019

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Altitude Sickness

Hypoxia

Study Results

No Results Posted as of May 17, 2022