Baro-reflex SensitivityHypoxiaNCT03439202
Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.
A study testing Hypoxia in people with Baro-reflex Sensitivity and Heart Rate Variability, run by Fliegerärztliches Institut at 1 site in Switzerland.
Trial summary
The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg, for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and other physiological variables in different normobaric and hypobaric hypoxic conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Baro-reflex Sensitivity, Heart Rate Variability, EEG, Microstates
- What is being tested?
- Hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Mar 2018to 14 Feb 2019
- 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
- Study Indication
- Male and Female subjects from 18 years to 40 years of age
- Healthy volunteer
- Signed Informed Consent after being informed
Who cannot join
- Contraindications to the study intervention.
- Define drugs, treatments or interventions not allowed during the study or for specific periods of time prior to the intervention,
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- Known or suspected non-compliance, drug or alcohol abuse,
- Previous problem with hypoxia or altitude exposure,
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- Known pathologies/diseases
- Relevant medical disorders
- Anemia or poor health
- History of flight sickness
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Aeromedical Center / Fliegerärztliches Institut
Dübendorf, Canton of Zurich, 8600
About this study
Official title: The Effects of Low Intensity Exercise in Hypobaric vs. Normobaric Normoxic and Hypoxic Conditions on Baroreflex Sensitivity, Physiological Responses and Cerebral Functions in Pilots.
The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg, for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and other physiological variables in different normobaric and hypobaric hypoxic conditions.
Read the detailed description
Subjects will bike at 1W/kg for 6 minutes at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Concentration performance also will be measured to better understand how hypobaric and hypoxia conditions may affect physiological responses, cerebral and cognitive functions.
- Conditions
- Baro-reflex Sensitivity, Heart Rate Variability, EEG, Microstates, Cerebral Blood Flow Regulation, Cerebral Oxygenation, Oxygen Saturation
- Being tested
- Hypoxia
- Keywords
- Hypoxia, Baro-reflex sensitivity, Low-intensity exercise, Hear rate variability, EEG, Concentration performance
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxiaOther
Also called Low-intensity cycling exercise
Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.
| Study group | Role | What they receive |
|---|---|---|
| No arm used | Other | No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study). Receives: Other: Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baro-reflex sensitivity
To test the strength of relationship between RR interval and systolic blood pressure in human. Measurement before and after low intensity exercise in each condition.
Measured: 6 minutes per record.
Secondary outcomes (4)
Concentration performance
Subjects will conduct a concentration test in each condition.
Measured: 4 minutes per test
EEG microstates
Microstates analysis to investigate how electrical cerebral activity is affected at rest in hypoxia and influenced by low intensity cycling exercise.
Measured: 6 minutes per record
Heart rate variability (HRV)
To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.
Measured: 6 minutes per record
Cerebral blood flow
Regulation of cerebral blood flow in hypoxia at rest and during low-intensity exercise. Measurement before, during and after low intensity exercise in each condition. 6 minutes recording per measurement.
Measured: 6 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 posted20 Feb 2018
- Study start19 Mar 2018
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baro-reflex SensitivityStudies 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
- Crossover randomized study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fliegerärztliches Institut
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Sponsor
- Investigators
- Denis Bron, Dr. med., Principal investigator, Aeromedical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439202
- Sponsor's protocol ID
- 2018-00006
- Other IDs
- 2018
- Acronym
- Hypoxia
- Status last verified
- Feb 2019
- First submitted
- 26 Jan 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Intensity Exercise in Hypobaric vs. Normobaric Normoxic and Hypoxic Conditions on Baroreflex Sensitivity, Physiological Responses and Cerebral Functions in Pilots.
- ClinicalTrials.gov ID
- NCT03439202
- Acronym / sponsor ID
- Hypoxia / 2018-00006
- Conditions
- Baro-reflex Sensitivity, Heart Rate Variability, EEG, Microstates, Cerebral Blood Flow Regulation, Cerebral Oxygenation, Oxygen Saturation
- Keywords
- Hypoxia, Baro-reflex sensitivity, Low-intensity exercise, Hear rate variability, EEG, Concentration performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fliegerärztliches InstitutUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 20 Feb 2018 (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 main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg, for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and other physiological variables in different normobaric and hypobaric hypoxic conditions.
Detailed description
Subjects will bike at 1W/kg for 6 minutes at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Concentration performance also will be measured to better understand how hypobaric and hypoxia conditions may affect physiological responses, cerebral and cognitive functions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Crossover randomized study
| Arm | Type | Receives |
|---|---|---|
| No arm used | Other | Other: HypoxiaNo drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Study Indication
- Male and Female subjects from 18 years to 40 years of age
- Healthy volunteer
- Signed Informed Consent after being informed
Key exclusion criteria (10 listed)
- Contraindications to the study intervention.
- Define drugs, treatments or interventions not allowed during the study or for specific periods of time prior to the intervention,
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- Known or suspected non-compliance, drug or alcohol abuse,
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 |
|---|---|---|
| HypoxiaAlso: Low-intensity cycling exerciseSubject will conduct low-intensity exercise on a bike in different hypoxic conditions. | Other | No arm used |
Primary outcome
Baro-reflex sensitivity
Time frame: 6 minutes per record.
To test the strength of relationship between RR interval and systolic blood pressure in human. Measurement before and after low intensity exercise in each condition.
4 secondary outcomes
Concentration performance
Time frame: 4 minutes per test
EEG microstates
Time frame: 6 minutes per record
Heart rate variability (HRV)
Time frame: 6 minutes per record
Cerebral blood flow
Time frame: 6 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 15 Feb 2019.
- Individual participant dataSharing planned: No
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.
Denis Bron, Dr. med. principal investigator
Aeromedical Center
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 Baro-reflex Sensitivity and Heart Rate Variability, 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 10 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 15 Feb 2019. 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?
Baro-reflex sensitivity (time frame: 6 minutes per record.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019; AzTrials last refreshed its copy on 27 Oct 2026.