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Hypoxia, AltitudeNCT03335917

Oxygen Transport in Normobaric vs. Hypobaric Hypoxia

A study testing Hypoxia and Exercise in people with Hypoxia, Altitude and Exercise, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1) Oxygen Transport in Normobaric versus Hypobaric Hypoxia. 2) The purpose of this study is to examine acute responses in arterial and muscle tissue oxygenation during incremental exercise in normobaric versus hypobaric hypoxia. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Hypoxia, Altitude, Exercise
What is being tested?
Hypoxia and Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
15 Aug 2017to 1 Jun 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 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must be recreationally active Recreationally active is defined as participating in moderate to vigorous physical activity for 30 minutes at least 3 days per week.-females or males between the ages of 19 and 45.
  • All participants must be considered "low risk" according to ACSM risk stratification.
  • participants must be free from any ECG or blood pressure abnormalities as assessed during maximal testing.

Who cannot join

  • All subjects who are considered higher than "low risk" according to the ACSM risk stratification guidelines will be excluded from this study.
  • Any participant under 19 years of age or over the age 45 and who list any health related condition that may interfere or become exacerbated by participating in this research would be excluded from this study.
  • Participants taking any prescription drugs, other than female contraceptives, will be excluded from participation.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska at Omaha

    Omaha, Nebraska, 68182

Other trials in United States

About this study

  1. Oxygen Transport in Normobaric versus Hypobaric Hypoxia. 2) The purpose of this study is to examine acute responses in arterial and muscle tissue oxygenation during incremental exercise in normobaric versus hypobaric hypoxia. 3) The participants in this study will consist of 12 recreationally active males and females between the ages of 19 and 45.Recreationally active is defined as participating in moderate to vigorous physical activity for 30 minutes at least 3 days per week.4) Subjects will complete an incremental cycle test to volitional fatigue in three conditions in a randomized counter-balanced order, normobaric normoxia (20.9% O2, 730 mmHg), normobaric hypoxia (14.3% O2, 730 mmHg) and hypobaric hypoxia (20.9% O2, 530mmHg). Two of the three trials will be conducted in an environmental chamber to simulate normobaric normoxia at 350 m (elevation of Omaha, NE) and normobaric hypoxia at 3094 m (elevation of Leadville, CO). The hypobaric hypoxia trial will be conducted in Leadville, Colorado at 3094 m. Trials will be separated by at least two days. Rating of perceived exertion, heart rate, blood oxygenation, respiration rate, muscle tissue oxygenation, and whole body gases will be analyzed during the trials. 5) There is no follow-up as a part of this study.
Read the detailed description

The specific objective of the study is to identify physiological differences between acute exposure to normobaric and hypobaric hypoxia.

The majority of well controlled research investigating the physiological effects of altitude have been conducted in chambers that create a hypoxic environment by reducing the fraction of oxygen in the environment (normobaric hypoxia). With actual altitude exposure, the fraction of oxygen remains constant but the barometric pressure providing the driving force for the binding of oxygen to hemoglobin is reduced (hypobaric hypoxia). Both circumstances should in theory lead to the same partial pressure of oxygen. Recent research has called the normobaric hypoxia model for altitude exposure into question and demonstrates that normobaric and hypobaric hypoxia may lead to differential physiological responses. Indeed, research from our lab has shown a higher heart rate and lower arterial oxygen saturation with hypobaric hypoxia compared to normobaric hypoxia. Others have also documented a further decrease in physical performance lower ventilatory response and pH, and higher oxidative stress in hypobaric hypoxia compared to normobaric hypoxia. The ability to interchange these methods of achieving a hypoxic environment is not without controversy. our lab has recently investigated the skeletal muscle transcriptional response after exposure to both normobaric and hypobaric hypoxia. The investigators found only limited differences in the muscle transcriptional response between the two forms of hypoxia despite differences in arterial oxygen saturation and heart rate. Clearly, more work is needed to determine the physiological aspects that may be differentially affected by normobaric and hypobaric hypoxia. This project will fill the knowledge gap of differences between forms of hypoxia in the resting and exercise response. Specifically, we will non-invasively determine the muscle oxygenation (NIRS) response that may help explain the lack of difference between the forms of hypoxia on the muscle transcriptional response. Furthermore, while heart rate has been shown to be differentially affected, no data currently exists on the variability of heart rate. It will determine the effects on heart rate variability (a marker of autonomic nervous system function and strong predictor of mortality). The addition of this data to the body of literature will have an impact on the physiological understanding of the effects of hypoxia and have major implications to the interpretation of previous research based on the experimental model used.

Being tested
Hypoxia, Exercise
Medical subject headings
Altitude Sickness, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypoxiaOther

    Participants will be exposed to hypoxia by reducing barometric pressure or by reducing oxygen concentration

  • ExerciseOther

    Graded cycling exercise to volitional fatigue

Study groups in NCT03335917
Study groupRoleWhat they receive
Normobaric NormoxiaPlacebo comparatorThis will serve as the exercise only control trial
Receives: Other: Exercise
Normobaric HypoxiaExperimentalThis arm will provide hypoxia by reducing the amount of oxygen concentration without changing the barometric pressure
Receives: Other: Hypoxia; Other: Exercise
Hypobaric HypoxiaExperimentalThis arm will provide hypoxia by reducing the barometric pressure without changing the oxygen concentration (terrestrial altitude exposure)
Receives: Other: Hypoxia; Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Muscle Oxygenation

    % O2 sat in muscle using NIRS

    Measured: change from baseline at 0 minutes after exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start15 Aug 2017
  3. Primary completion1 Jun 2018
  4. Study completion1 Jun 2018

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized,Counter Balanced, Repeated Measures, Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03335917
Sponsor's protocol ID
0209-17-FB
Status last verified
Sep 2023
First submitted
5 Sep 2017
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to make IPD available to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Hypoxia and Exercise in people with Hypoxia, Altitude and Exercise, run by University of Nebraska at 1 site in United States.

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 3 inclusion and 3 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 29 Sep 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Change in Muscle Oxygenation (time frame: change from baseline at 0 minutes after exercise). 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 29 Sep 2023; AzTrials last refreshed its copy on 29 Oct 2026.

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