The Effects of Hypobaria vs Hypoxia on Cerebral Functions.

Cerebral Hypoxia Clinical Trial

— Hypoxia  

Official title:

The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303118
• Other study ID #: 2017-00752
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: March 5, 2018

Study information

• Verified date: August 2021
• Source: Fliegerärztliches Institut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will investigate the effect of hypobaria and hypoxia on physiological responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation, brain's activity and concentration performance.

Description:

The main goal of this project is to investigate how hypoxia affects cognitive functions. The KLT-R test asses the concentration level of a person. Subjects will do this test at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Investigators' first hypothesis is that concentration level will be altered by hypoxia. The higher altitude the subjects are, the more the concentration would be altered. KLT-R performance would be impaired by hypoxia compare to sea level performance.

The primary endpoint of this project is to investigate how KLT-R performance is affected by the different hypoxic conditions. KLT-R test will be passed nine times in total during the test visit. There will be a pre-test; a test at each of the conditions (3000m HH, 5500m HH, 5500m NH and 5500m HN); between each condition at sea level (to have a new baseline before each condition) and a post-test at the end of the protocol. To avoid influence of fatigue, all conditions will be randomized.

The second endpoint of this study is how the brain electrical activity is modulated by hypoxia. Micro-states also will be measure during hypobaric hypoxia conditions (3000m HH and 5500m HH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• No history of flight sickness

• No relevant medical diseases

• Age 18 - 40 years

• Written consent acceptance

Exclusion Criteria:

• Known pathologies

• Relevant medical disorders

• Drug addiction

• Anemia or poor health

• People who have already had problems with elevation

Related Conditions & MeSH terms

• Cerebral Hypoxia
• Hypoxia
• Hypoxia, Brain

Intervention

Other:
• Hypoxia
No drug or product will be used in this study. No medication will be give to the participants. No arm will be used for product administration.

Locations

Country	Name	City	State
Switzerland	Mathias Aebi	Dübendorf	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Fliegerärztliches Institut

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral vaso-reactivity	Cerebral vasoreactivity after 1 minute hyperventilation and 3 minutes breathing of 5% CO2 mixture.	8 Minutes per test
Primary	Concentration performance	Performance of concentration at different altitude levels.	4 minutes per test
Secondary	EEG micro-states	5 minutes recording in each conditions, eyes closed, at rest.	5 minutes per record