Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia

NCT03823677 | Completed

• 1 other identifier: DRU-EMO-KOELN
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxia, Altitude

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (15)

control group 15

NO INTERVENTION

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

control group 30

NO INTERVENTION

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

control group 60

NO INTERVENTION

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

hypoxia 5000ft group 15

EXPERIMENTAL

Intervention: 15 minutes hypoxia

Procedure: Hypoxia

hypoxia 5000ft group 30

EXPERIMENTAL

Intervention: 30 minutes hypoxia

Procedure: Hypoxia

hypoxia 5000ft group 60

EXPERIMENTAL

Intervention: 60 minutes hypoxia

Procedure: Hypoxia

hypoxia 8000ft group 15

EXPERIMENTAL

Intervention: 15 minutes hypoxia

Procedure: Hypoxia

hypoxia 8000ft group 30

EXPERIMENTAL

Intervention: 30 minutes hypoxia

Procedure: Hypoxia

hypoxia 8000ft group 60

EXPERIMENTAL

Intervention: 60 minutes hypoxia

Procedure: Hypoxia

hypoxia 10000ft group 15

EXPERIMENTAL

Intervention: 15 minutes hypoxia

Procedure: Hypoxia

hypoxia 10000ft group 30

EXPERIMENTAL

Intervention: 30 minutes hypoxia

Procedure: Hypoxia

hypoxia 10000ft group 60

EXPERIMENTAL

Intervention: 60 minutes hypoxia

Procedure: Hypoxia

hypoxia 15000ft group 15

EXPERIMENTAL

Intervention: 15 minutes hypoxia

Procedure: Hypoxia

hypoxia 15000ft group 30

EXPERIMENTAL

Intervention: 30 minutes hypoxia

Procedure: Hypoxia

hypoxia 15000ft group 60

EXPERIMENTAL

Intervention: 60 minutes hypoxia

Procedure: Hypoxia

Interventions

Hypoxia PROCEDURE

hypoxia

hypoxia 10000ft group 15; hypoxia 10000ft group 30; hypoxia 10000ft group 60; hypoxia 15000ft group 15; hypoxia 15000ft group 30; hypoxia 15000ft 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Helathy

You may not qualify if:

• Ear problems

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jochen Hinkelbein

  University Hospital of Cologne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: volunteers
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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 Record Dates

• First Submitted: January 7, 2019
• First Posted: January 30, 2019
• Study Start: July 1, 2018
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)