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The Effects of Hypobaria vs Hypoxia on Cerebral Functions.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03303118
Acronym
Hypoxia
Enrollment
17
Registered
2017-10-05
Start date
2017-11-16
Completion date
2018-03-05
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hypoxia

Keywords

Hypoxia, Brain, Cerebral vaso-reactivity, EEG, Concentration performance, Cerebral oxygenation, Cerebral blood-flow, Heart rate variability

Brief 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.

Detailed 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).

Interventions

OTHERHypoxia

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.

Sponsors

Fliegerärztliches Institut
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Single-Blind study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Concentration performance4 minutes per testPerformance of concentration at different altitude levels.

Secondary

MeasureTime frameDescription
EEG micro-states5 minutes per record5 minutes recording in each conditions, eyes closed, at rest.

Other

MeasureTime frameDescription
Cerebral vaso-reactivity8 Minutes per testCerebral vasoreactivity after 1 minute hyperventilation and 3 minutes breathing of 5% CO2 mixture.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026