The Effects of Hypobaria vs Hypoxia on Cerebral Functions.

• Sponsor: Fliegerärztliches Institut (Other)
• Overall Status: Completed
• CT.gov ID: NCT03303118
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Hypoxia	Other: Hypoxia	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single-Blind study.Single-Blind study.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.
• Actual Study Start Date: Nov 16, 2017
• Actual Primary Completion Date: Mar 5, 2018
• Actual Study Completion Date: Mar 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Left 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.

Outcome Measures

Primary Outcome Measures

1. Concentration performance [4 minutes per test]

   Performance of concentration at different altitude levels.

Secondary Outcome Measures

1. EEG micro-states [5 minutes per record]

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

Other Outcome Measures

1. Cerebral vaso-reactivity [8 Minutes per test]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mathias Aebi	Dübendorf	Zürich	Switzerland	8600

Sponsors and Collaborators

• Fliegerärztliches Institut

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mathias Aebi, PhD, Dr. med Denis Bron, Fliegerärztliches Institut
• ClinicalTrials.gov Identifier: NCT03303118
• Other Study ID Numbers: 2017-00752
• First Posted: Oct 5, 2017
• Last Update Posted: Aug 18, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mathias Aebi, PhD, Dr. med Denis Bron, Fliegerärztliches Institut: Hypoxia; Brain; Cerebral vaso-reactivity; EEG; Concentration performance; Cerebral oxygenation; Cerebral blood-flow; Heart rate variability
• Additional relevant MeSH terms: Hypoxia, Brain; Hypoxia

Study Results

No Results Posted as of Aug 18, 2021