ClinicalTrials.gg
CompletedNCT03439202HypoxiaUpdated Feb 15, 2019

Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.

An interventional study of Hypoxia in Baro-reflex Sensitivity, Heart Rate Variability and EEG, Microstates, 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 2019-02-15.

Sponsored by Fliegerärztliches Institut · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 41 studies in Hypoxia with a site in Switzerland — 12 open to participants now, 17 under way, none of them phase 3. Hypoxia · Switzerland.

Enrollment
21st of 37
20 · median 24
Started
2018
with 2 others
No phase
31 of 41
12 open now
Registered
13th of 41
by date
Lead sponsor
2 of 41
Fliegerärztliches Institut

Among the 41 studies in Hypoxia with a site in Switzerland, this one is the 21st largest by enrollment of the 37 interventional ones that give a count, is one of 3 that started in 2018, is one of 31 with no phase, and was the 13th registered.

Hypoxia

1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 769 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Open to participants now

12 of the 41 studies in Hypoxia with a site in Switzerland are open now.

All 12 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 125 Hypoxia studies recruiting now, 53 (42%) set no upper age limit and 45 (36%) stop at 75 or younger; 15 take children under 18; 33 take healthy volunteers.

This study: 18 Years to 40 Years · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 41 studies in Hypoxia with a site in Switzerland, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Baro-reflex Sensitivity
  • Heart Rate Variability
  • EEG, Microstates
  • Cerebral Blood Flow Regulation
  • Cerebral Oxygenation
  • Oxygen Saturation
  • Concentration Performance

Browse trials for

Keywords

  • Hypoxia
  • Baro-reflex sensitivity
  • Low-intensity exercise
  • Hear rate variability
  • EEG
  • Concentration performance
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Study Indication
  • Male and Female subjects from 18 years to 40 years of age
  • Healthy volunteer
  • Signed after being informed

Exclusion criteria

Exclusion Criteria:

  • 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,
  • Known pathologies/diseases
  • Relevant medical disorders
  • Anemia or poor health
  • History of flight sickness
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    No arm used

    No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study).

    Other: Hypoxia

Interventions

  • OtherHypoxia

    Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.

    Also known as: Low-intensity cycling exercise

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 minutes per record.

Secondary outcomes

  1. Concentration performance

    Subjects will conduct a concentration test in each condition.

    Time frame: 4 minutes per test

  2. EEG microstates

    Microstates analysis to investigate how electrical cerebral activity is affected at rest in hypoxia and influenced by low intensity cycling exercise.

    Time frame: 6 minutes per record

  3. Heart rate variability (HRV)

    To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.

    Time frame: 6 minutes per record

  4. 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.

    Time frame: 6 minutes per record.

07

Study locations

1 site
  • Aeromedical Center / Fliegerärztliches Institut
    Dübendorf, ZH 8600, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Feb 2019, 10 months.

Of 321 non-industry interventional studies with no phase under Hypoxia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 10 months is below that.

Counting every sponsor, half of 351 studies reached it within 12 months; a quarter within 3 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 20, 2018
StartActual
Mar 19, 2018
Primary completionActual
Feb 14, 2019
CompletionActual
Feb 14, 2019
Last update
Feb 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03439202
Lead sponsor
Fliegerärztliches Institut
Collaborators
University of Lausanne
Responsible party
Sponsor
First posted
Feb 20, 2018
Start date
Mar 19, 2018
Primary completion
Feb 14, 2019
Completion
Feb 14, 2019
Last update
Feb 15, 2019

Study contacts

Denis Bron, Dr. med.
principal investigator · Aeromedical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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