An interventional study of Hypoxia and Exercise in Hypoxia, Altitude and Exercise, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by University of Nebraska · Not applicable, Interventional, and Basic science
Among 39 studies in Altitude Sickness with a site in United States — 3 open to participants now, 5 under way, none of them phase 3. Altitude Sickness · United States.
Among the 39 studies in Altitude Sickness with a site in United States, this one is the 34th largest by enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2017, is one of 13 with no phase, and was the 15th registered.
216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.
Browse Altitude Sickness studies →3 of the 39 studies in Altitude Sickness with a site in United States are open now. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
University of Colorado, Denver · Sites in United States
University of Colorado, Denver · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Altitude Sickness studies recruiting now, 4 (24%) set no upper age limit and 10 (59%) stop at 75 or younger; 2 take children under 18; 10 take healthy volunteers.
This study: 19 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 4 · Phase 3 4 · Phase 4 9
First in 2006; this study’s year is marked. 4 started in 2017.
This study's enrollment of 12 is below the median of 34 across 178 interventional studies indexed under Altitude Sickness.
Median enrollment 33 across the 37 interventional studies, 67 across the 2 observational. Of the 34 that completed or were terminated, 12 (35%) have results posted.
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2 of 39 have an industry lead sponsor. The 10 most frequent:
University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
University of Nebraska has 1 study filed under Altitude Sickness — fewer than ten, so there is no comparison to draw.
2 of the studies in Altitude Sickness with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06040268University of Colorado, DenverAdvair HFA in Healthy and HAPE Predisposed Subjects | 2026-12-01 |
| NCT02391519University of Colorado, DenverEffects of High Altitude on AMPK Activation | 2026-12-31 |
Among the 39 studies in Altitude Sickness with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Exclusion Criteria:
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This will serve as the exercise only control trial
Other: Exercise
This arm will provide hypoxia by reducing the amount of oxygen concentration without changing the barometric pressure
Other: Hypoxia · Other: Exercise
This arm will provide hypoxia by reducing the barometric pressure without changing the oxygen concentration (terrestrial altitude exposure)
Other: Hypoxia · Other: Exercise
Participants will be exposed to hypoxia by reducing barometric pressure or by reducing oxygen concentration
Graded cycling exercise to volitional fatigue
Change in Muscle Oxygenation
% O2 sat in muscle using NIRS
Time frame: change from baseline at 0 minutes after exercise
Plan to share: No — No plan to make IPD available to other researchers.
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Jun 2018, 9 months.
Of 76 non-industry interventional studies with no phase under Altitude Sickness, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 9 months is close to that.
Counting every sponsor, half of 76 studies reached it within 9 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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