An interventional study of Hypoxia in Cerebral Hypoxia, sponsored by Fliegerärztliches Institut. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by Fliegerärztliches Institut · Not applicable, Interventional, and Other
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.
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).
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →Fliegerärztliches Institut is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
No product administration will be done in this study.
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.
Concentration performance
Performance of concentration at different altitude levels.
Time frame: 4 minutes per test
EEG micro-states
5 minutes recording in each conditions, eyes closed, at rest.
Time frame: 5 minutes per record
Cerebral vaso-reactivity
Cerebral vasoreactivity after 1 minute hyperventilation and 3 minutes breathing of 5% CO2 mixture.
Time frame: 8 Minutes per test
Plan to share: No — Results will be shared in scientific publications by the end of this year and in 2018.
Ran from Nov 2017 to primary completion in Mar 2018, 3 months.
Of 33 non-industry interventional studies with no phase under Hypoxia, Brain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 44. This study's 3 months is below that.
Counting every sponsor, half of 33 studies reached it within 20 months; a quarter within 7 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Fliegerärztliches Institut