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Completed

NCT Number: NCT03823677

Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia

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

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Key information

Conditions

Hypoxia, Altitude Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Helathy

Exclusion criteria

  • Ear problems

Treatment and study plan

Hypoxia

Procedure

hypoxia

Primary outcomes

  1. 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

  2. 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

  3. Emotional assessment tears

    Time frame: Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes

    Emotional tears test

  4. 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.

  5. 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,

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Köln

Other

Registry information

Acronym: DRU-EMO-K

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2019
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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