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Completed

NCT Number: NCT03303118

The Effects of Hypobaria vs Hypoxia on Cerebral Functions.

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mathias Aebi

Dübendorf, Canton of Zurich, 8600, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Hypoxia

Other

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.

Primary outcomes

  1. Concentration performance

    Time frame: 4 minutes per test

    Performance of concentration at different altitude levels.

Secondary outcomes

  1. EEG micro-states

    Time frame: 5 minutes per record

    5 minutes recording in each conditions, eyes closed, at rest.

Other outcomes

  1. Cerebral vaso-reactivity

    Time frame: 8 Minutes per test

    Cerebral vasoreactivity after 1 minute hyperventilation and 3 minutes breathing of 5% CO2 mixture.

Sponsors and collaborators

Lead sponsor

Fliegerärztliches Institut

Other

Registry information

Official study title

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

Acronym: Hypoxia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2017
Registry last updated
Aug 18, 2021

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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