Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia

Hypoxia, Altitude Clinical Trial

— DRU-EMO-K  

Official title:

Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823677
• Other study ID #: DRU-EMO-KOELN
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Universitätsklinikum Köln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Helathy

Exclusion Criteria:

• Ear problems

Related Conditions & MeSH terms

• Altitude Sickness
• Hypoxia
• Hypoxia, Altitude

Intervention

Procedure:
• Hypoxia
hypoxia

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Emotional assessment tears	Emotional tears test	Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes
Primary	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
Primary	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