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

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ClinicalTrials.gov Identifier: NCT03823677

Recruitment Status : Recruiting

First Posted : January 30, 2019

Last Update Posted : April 29, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Jochen Hinkelbein, Universitätsklinikum Köln

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	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated 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.
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 :	July 1, 2018
Estimated Primary Completion Date :	December 31, 2021
Estimated Study Completion Date :	December 31, 2021

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Acute Mountain Sickness

U.S. FDA Resources

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 [ 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,

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Helathy

Exclusion Criteria:

Ear problems

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823677

Contacts

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Contact: Jochen Hinkelbein, MD	+49221 ext 47882042	jochen.hinkelbein@gmail.com

Locations

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Germany
University Hospital of Cologne	Recruiting
Cologne, NRW, Germany, 50937
Contact: Jochen Hinkelbein, MD +49221478 ext -97728 jochen.hinkelbein@uk-koeln.de
Principal Investigator: Jochen Hinkelbein, MD

Sponsors and Collaborators

Universitätsklinikum Köln

Investigators

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Study Chair:	Jochen Hinkelbein	University Hospital of Cologne

More Information

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Responsible Party:	Jochen Hinkelbein, Clinical Professor, Universitätsklinikum Köln
ClinicalTrials.gov Identifier:	NCT03823677
Other Study ID Numbers:	DRU-EMO-KOELN
First Posted:	January 30, 2019 Key Record Dates
Last Update Posted:	April 29, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Altitude Sickness Hypoxia Signs and Symptoms, Respiratory Respiration Disorders Respiratory Tract Diseases

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