Back to resultsThe Effects of Hypobaria vs Hypoxia on Cerebral Functions. (Hypoxia)
Primary Purpose
Cerebral Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hypoxia
Sponsored by
About this trial
This is an interventional other trial for Cerebral Hypoxia focused on measuring Hypoxia, Brain, Cerebral vaso-reactivity, EEG, Concentration performance, Cerebral oxygenation, Cerebral blood-flow, Heart rate variability
Eligibility Criteria
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
Sites / Locations
- Mathias Aebi
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Left
Arm Description
No product administration will be done in this study.
Outcomes
Primary Outcome Measures
Concentration performance
Performance of concentration at different altitude levels.
Secondary Outcome Measures
EEG micro-states
5 minutes recording in each conditions, eyes closed, at rest.
Full Information
NCT ID
NCT03303118
First Posted
October 2, 2017
Last Updated
August 17, 2021
Sponsor
Fliegerärztliches Institut
1. Study Identification
Unique Protocol Identification Number
NCT03303118
Brief Title
The Effects of Hypobaria vs Hypoxia on Cerebral Functions.
Acronym
Hypoxia
Official Title
The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
March 5, 2018 (Actual)
Study Completion Date
March 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fliegerärztliches Institut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hypoxia
Keywords
Hypoxia, Brain, Cerebral vaso-reactivity, EEG, Concentration performance, Cerebral oxygenation, Cerebral blood-flow, Heart rate variability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-Blind study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Left
Arm Type
Other
Arm Description
No product administration will be done in this study.
Intervention Type
Other
Intervention Name(s)
Hypoxia
Intervention Description
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 Outcome Measure Information:
Title
Concentration performance
Description
Performance of concentration at different altitude levels.
Time Frame
4 minutes per test
Secondary Outcome Measure Information:
Title
EEG micro-states
Description
5 minutes recording in each conditions, eyes closed, at rest.
Time Frame
5 minutes per record
Other Pre-specified Outcome Measures:
Title
Cerebral vaso-reactivity
Description
Cerebral vasoreactivity after 1 minute hyperventilation and 3 minutes breathing of 5% CO2 mixture.
Time Frame
8 Minutes per test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mathias Aebi
City
Dübendorf
State/Province
Zürich
ZIP/Postal Code
8600
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Results will be shared in scientific publications by the end of this year and in 2018.
Citations:
PubMed Identifier
32097541
Citation
Aebi MR, Bourdillon N, Kunz A, Bron D, Millet GP. Specific effect of hypobaria on cerebrovascular hypercapnic responses in hypoxia. Physiol Rep. 2020 Feb;8(4):e14372. doi: 10.14814/phy2.14372.
Results Reference
derived
Learn more about this trial
The Effects of Hypobaria vs Hypoxia on Cerebral Functions.
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