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Active, not recruitingNCT06901284Updated Jan 30, 2026

Graded Exercise Hypoxia Testing

An observational study in Hypoxia, sponsored by Mayo Clinic. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
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Study summary

The purpose of this study is to develop a single, standardized test to determine how individuals tolerate acute hypoxia in a stepwise fashion. We aim to evaluate the association between multiple factors, such as ventilatory compensation, heart rate response, acid-base changes, sex, pulmonary function, etc, which may explain why some individuals tolerate exercise in hypoxia better than others. Identifying these factors of association will inform future pharmacological and non-pharmacological attempts to combat acute hypoxic exercise.

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Conditions studied

  • Hypoxia

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's planned enrollment of 50 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A total of 50 participants (25 female, 25 male) will be recruited for this study. Participants will be recruited from the general population.

Inclusion criteria

  • Physically active (≥150 minutes of moderate physical activity per week)

Exclusion criteria

Exclusion Criteria:

  • Contraindications to exercise testing
  • Currently pregnant
  • Musculoskeletal or metabolic disease
  • Allergies to lidocaine
  • Body-mass index ≤18 or ≥35 kg·m-2
  • Pacemaker
  • No confounding cardiorespiratory disease
  • Persistent tobacco use (>15 pack years)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study group

    50 participants (25 female, 25 male) who are physically active for at least 150 minutes per week, at a moderate activity level.

    Diagnostic Test: Graded Exercise Test · Diagnostic Test: Graded Hypoxia Exercise Test

Interventions

  • Diagnostic testGraded Exercise Test

    Participants will perform a graded exercise test on either a cycle ergometer or treadmill. The testing protocol will begin with a 5- 10 min warm-up of either cycling or running/walking at the participants preferred pace. If the graded exercise test is on a bike, exercise will begin at wattage that elicits \~50% of their heart rate max, HRmax = 208 - 0.7 × age and increase by either 10W, 15W, or 20W every two minutes in a stepwise fashion until symptom limitation. The step of the wattage increase will be at the discretion of the investigators. If the graded exercise test is on a treadmill, the test will begin at a speed that elicits \~50% of predicted HRmax. Following, the speed of the treadmill will increase 0.5 mph (0.8 km/hr) every two minutes in a stepwise fashion until symptom limitation. If the participant maxes out the speed of the treadmill, we will increase the grade 2% every 2-minutes until symptom limitation.

  • Diagnostic testGraded Hypoxia Exercise Test

    Participants will perform a single constant work rate exercise tests during graded hypoxia. They will be outfitted with either a facemask or mouthpiece connected to a uni-directional breathing valve. During inspiration, subjects will breathe from a closed-system Douglas bag balloon reservoir (\~200 L) connected to the value on the inspired side via air-tight clean-bor tubing. The participant will complete the same mode of exercise as they did during visit 1, either bike or treadmill. The resistance on the bike or incline of the treadmill will be set to elicit an intensity equivalent to \~50% of their V̇O2max determined during visit 1. Participants will complete 5-minute stages over a range of FiO2 values. The exercise test will begin in an FiO2=0.21 (i.e. room air). Following this first 5-min stage the FiO2 will increase to 0.25, afterwards, participants will complete another stage at FiO2=0.21 and then decrease in a stepwise fashion every 5-minutes.

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What researchers measure

Primary outcomes

  1. PaO₂/FiO₂ Ratio

    The PaO₂/FiO₂ ratio is a widely used measure of oxygenation efficiency in the lungs. It compares the arterial oxygen partial pressure (PaO₂, measured in mmHg) to the fraction of inspired oxygen (FiO₂, expressed as a decimal). The ratio provides insight into the ability of the lungs to transfer oxygen into the bloodstream. A PaO₂/FiO₂ ratio of 300-400 is considered to be mild hypoxemia. Participants are considered as poorly tolerating hypoxia if their ratio is \<400 and good at tolerating hypoxia if their ratio is \>400.

    Time frame: 30 minutes

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Study locations

2 sites
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
  • St. Mary's Hospital
    Rochester, Minnesota 55902, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06901284
Lead sponsor
Mayo Clinic
Responsible party
Michael J. Joyner, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 28, 2025
Start date
Apr 15, 2025
Primary completion
Apr 24, 2027 (estimated)
Completion
Apr 24, 2028 (estimated)
Last update
Jan 30, 2026

Study contacts

Michael Joyner, M.D.
principal investigator · Mayo Clinic

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 active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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