Cerebral HypoxiaHypoxiaNCT03303118
The Effects of Hypobaria vs Hypoxia on Cerebral Functions.
A study testing Hypoxia in people with Cerebral Hypoxia, run by Fliegerärztliches Institut at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Hypoxia
- What is being tested?
- Hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Nov 2017to 5 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No history of flight sickness
- No relevant medical diseases
- Age 18 - 40 years
- Written consent acceptance
Who cannot join
- Known pathologies
- Relevant medical disorders
- Drug addiction
- Anemia or poor health
- People who have already had problems with elevation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.
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.
Read the 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).
- Conditions
- Cerebral Hypoxia
- Being tested
- Hypoxia
- Keywords
- Hypoxia, Brain, Cerebral vaso-reactivity, EEG, Concentration performance, Cerebral oxygenation, Cerebral blood-flow, Heart rate variability
- Medical subject headings
- Hypoxia, Brain, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Left | Other | No product administration will be done in this study. Receives: Other: Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration performance
Performance of concentration at different altitude levels.
Measured: 4 minutes per test
Secondary outcomes (1)
EEG micro-states
5 minutes recording in each conditions, eyes closed, at rest.
Measured: 5 minutes per record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start16 Nov 2017
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Blind study.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fliegerärztliches Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Aebi, PhD, Fliegerärztliches Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303118
- Sponsor's protocol ID
- 2017-00752
- Other IDs
- 2017
- Acronym
- Hypoxia
- Status last verified
- Aug 2021
- First submitted
- 2 Oct 2017
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be shared in scientific publications by the end of this year and in 2018.
Publications
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.
PubMed 32097541
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.
- ClinicalTrials.gov ID
- NCT03303118
- Acronym / sponsor ID
- Hypoxia / 2017-00752
- Conditions
- Cerebral Hypoxia
- Keywords
- Hypoxia, Brain, Cerebral vaso-reactivity, EEG, Concentration performance, Cerebral oxygenation, Cerebral blood-flow, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fliegerärztliches InstitutUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Blind study.
| Arm | Type | Receives |
|---|---|---|
| Left | Other | Other: HypoxiaNo product administration will be done in this study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No history of flight sickness
- No relevant medical diseases
- Age 18 - 40 years
- Written consent acceptance
Key exclusion criteria (5 listed)
- Known pathologies
- Relevant medical disorders
- Drug addiction
- Anemia or poor health
- People who have already had problems with elevation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypoxiaNo 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. | Other | Left |
Primary outcome
Concentration performance
Time frame: 4 minutes per test
Performance of concentration at different altitude levels.
1 secondary outcome
EEG micro-states
Time frame: 5 minutes per record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Derived from this study: PubMed 32097541Aebi 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.
- Individual participant dataSharing planned: No. Results will be shared in scientific publications by the end of this year and in 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia in people with Cerebral Hypoxia, run by Fliegerärztliches Institut at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration performance (time frame: 4 minutes per test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03303118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.