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

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

Study Overview

• Status: Completed
• Conditions: Hypoxia, Altitude
• Intervention / Treatment: Procedure: Hypoxia

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50937
      • University Hospital of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Helathy

Exclusion Criteria:

• Ear problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

15

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein Expression before hypoxia	proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics	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	Measurement immediately and at termination (i.e., 1 minute after) of hypoxia/experiment
Emotional assessment tears	Emotional tears test	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.	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,	Measurement in the pressure chamber after stroop test (i.e. 20 minutes after start). duration 10 minutes

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Investigators: Study Chair: Jochen Hinkelbein, University Hospital of Cologne

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): April 30, 2022

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Altitude Sickness; Hypoxia
• Other Study ID Numbers: DRU-EMO-KOELN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No