HypoxiaHiReach 2013NCT01953198
High Altitude Medical Research Expedition Himlung 2013 - a Study of Human Adaption to Hypoxia
An observational study of Hypoxia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The aim of the project "High Altitude Medical Research Expedition Himlung 2013" (HiReach2013) is to comprehensively investigate the cerebral, cardiovascular and pulmonary adaptation and the reactions of the human immune system during an ascent to extreme altitudes of over 7000 m. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Hypobaric hypoxia
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Jun 2013
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy and trained volunteers with basic mountaineering experience
Who may be able to join
- Subjects must be healthy, well trained and have basic mountaineering experience
- Written informed consent
Who cannot join
- Subjects with any type of cardiac and or respiratory disease
- Subjects with diabetes mellitus type I or II
- Regular intake of beta-blockers, ACE-inhibitors, nitrates and calcium antagonists as well as corticosteroids or anti-inflammatory medication
- Subjects who developed high altitude pulmonary edema after a rapid ascent (< 3 nights) at altitudes below 3500m
- Subjects who developed severe acute mountain sickness and/or high altitude cerebral edema after rapid ascent to altitudes below 3500m
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Altitude Medical Research Expedition Himlung 2013 - an Observational Cohort Study of Human Adaption to Hypobaric Hypoxia
The aim of the project "High Altitude Medical Research Expedition Himlung 2013" (HiReach2013) is to comprehensively investigate the cerebral, cardiovascular and pulmonary adaptation and the reactions of the human immune system during an ascent to extreme altitudes of over 7000 m. A total of 44 healthy and trained volunteers will be included in the study after written informed consent has been obtained.Baseline sea level clinical examination will be performed in Bern, Switzerland (BE1) at 550 m 8 to 4 weeks before departure. High altitude research facilities will be available at the altitudes of 5000m, 6100m and 6900m. Post-expedition examination will be performed within 2 to 6 weeks after the end of the expedition in Bern. In the context of 3 sub-projects specific measurements and examinations are performed.
These include: cMRI before and after the climb and neurovascular doppler examination during the climb; blood sampling for coagulation studies, cardiac and thoracic ultrasound, stress tests for assessment of cardiovascular performance.
Read the detailed description
Background
Altitude related medical problems are gaining more importance and attention as an ever increasing number of people travel to higher altitudes for work or pleasure. Resort towns in Europe and the Western United States at elevations in the 2000 m to 3000 m range attract millions of visitors annually. Many more visit cities in South America and Asia situated above 3000 m. In addition, tens of thousands of travelers, trekkers, and skiers worldwide ascend to elevations in the range of 3000 to 5500 m. An ever-increasing number of recreational climbers attempt ascents of summits of very high (3500 m to 5500 m) or extreme (>5500 m) altitudes. The Nepalese Ministry of Tourism and Civil Aviation and the Nepal Mountaineering Association reported having issued permits to 6032 climbers for peaks higher than 6000 m in the year 2010 alone. When considering that the number of people residing at high altitude is bound to increase, it is of importance to further deepen our understanding of the physiologic changes and dangers associated with exposure to high altitude. Oxygen homeostasis is essential for survival of healthy humans at high altitudes. Various physiological changes involving different organ systems occur during exposition and acclimatization to hypobaric hypoxia in the context of a high altitude sojourn. These include marked adaptations of pulmonary and systemic vascular function, changes in cerebral perfusion and metabolism, physiologic and metabolic adaptations of the immune system and innate defense mechanisms against infection. These changes are a consequence of tissue hypoxia per se or can be mediated by hypoxia induced activation of sympathoadrenal pathways. An example of important research activities in recent years is the discovery of hypoxia-inducible factor 1 alpha (HIF1α) and its role in oxygen homoeostasis by regulation of multiple gene loci. Additionally, as a result of hypoxia induced increase in oxidative/reductive stress, enhanced generation of reactive oxygen (ROS) and nitrogen species (RNS), altered activity of antioxidant systems, and related oxidative damage to lipids, proteins, and DNA can occur as well as injury at the cellular, sub-cellular and molecular levels. These short-lived intermediates include among others superoxide anion (O2), hydrogen peroxide (H2O2), and hypochloride (HOCI. In addition, hydroxyl radicals (OH), hydroxide ions (OH) and superoxide radicals (O2-) are highly reactive members of the ROS family that accumulate under certain physiological and pathophysiological conditions. As a consequence, prolonged hypobaric hypoxia leads to systemic oxidative stress similar to severe inflammation.
Tissue hypoxia and increased oxidative stress as well as adaptive or reactive changes in sympathoadrenal and neuroendocrine processes also occur in various disease states. Hypoxia per se plays an important role in the pathogenesis of major causes of mortality, including cancer, cerebral and myocardial ischemia, and chronic heart and lung disease. Global hypoxemia is a common problem in critically ill patients: In patients with pulmonary failure profound hypoxia can occur due to ventilation/perfusion mismatch or impaired diffusion capacity across the alveolo-capillary membrane despite best medical support including mechanical ventilation. Oxygen delivery to tissues might also be impaired due to low cardiac output or reduced oxygen carrying capacity in anemia. Microcirculatory dysfunction - occurring in the context of severe sepsis - can lead to local hypoxia on a cellular level even in patients with normal or increased arterial oxygen content and oxygen delivery.
In critically ill patients cellular hypoxia induces oxidative stress which can deplete cellular antioxidative capacities and lead to impaired ability to use available oxygen. Depleted levels of reduced glutathione, an important intra-mitochondrial antioxidant, in combination with increased generation of ROS and RNS seem to inhibit oxidative phosphorylation and ATP generation. There is increasing interest in ROS-intermediates and their role in the progression and modulation of vascular dysfunction and remodelling seen in different chronic disease entities, such as diabetes mellitus, chronic heart failure or chronic obstructive pulmonary disease (COPD) and development of pulmonary hypertension (PHT). The mechanisms of ROS-generation are not fully understood. ROS are produced in leukocytes, but the generation of ROS might also occur through disruption of the electron transport chain in mitochondria. The resulting mitochondrial dysfunction has been described as an additional factor causing pulmonary vasoconstriction and remodelling in PHT. In hypoxic patients with respiratory failure an increase of pulmonary vascular pressure frequently occurs (WHO Class III - pulmonary hypertension) which may worsen hypoxemia by impairing lung perfusion. If this increase is caused by a direct vasoconstrictive effect of hypoxia on the pulmonary endothelial cells or by an increase in ROS is still not fully understood.
Generally, the mechanisms leading to adaptation to prolonged hypoxic conditions in healthy humans and in critically ill patients are not well understood. In the context of critical illness these mechanisms are difficult to explore due to the heterogeneity of patients and precipitating illnesses. Furthermore, effects of hypoxia and concurring disease related processes are difficult or impossible to distinguish. Animal models of critical illness might have substantial limitations and often do not represent the human patient. It has been suggested that the physiological and pathophysiological responses to hypobaric hypoxia may be similar to responses seen in critical illness. In the context of a high altitude expedition human subjects can safely be submitted to prolonged hypoxia and oxidative stress and the resulting cerebral, cardiovascular and pulmonary adaptation and changes in mitochondrial function, inflammatory cascade, and coagulatory activity can be explored in a controlled fashion. The study of human responses to hypoxia occurring in a hypobaric environment in healthy volunteers ascending to high altitudes may therefore serve as a model of isolated hypoxia and might help to improve our understanding of the effects in critically ill patients.
Objective
The aim of the project "High Altitude Medical Research Expedition Himlung 2013" (HiReach2013) is to comprehensively investigate the cerebral, cardiovascular and pulmonary adaptation and the reactions of the human coagulation system during an ascent to extreme altitudes of over 7000 m.
Methods
Cardiopulmonary exercise testing will be done using a testing system on a bicycle using a roller trainer for standardization and regulation of the work load. Static and dynamic lung volumes will be assessed at each study site. The measurements will include the assessment DLCO using a commercially available spirometer. Transthoracic Doppler echocardiography will be performed for assessment of systolic/diastolic cardiac function and pulmonary artery pressures. Lung ultrasound will be applied in each subject at each study site to quantify extravascular lung water by ultrasound lung comets. Microparticle measurements will be performed using an Annexin V based ELISA. Cerebral blood flow velocity will be measured from a middle cerebral artery using transcranial Doppler. Structural cerebral changes and cerebral volume will be assessed with MRI of the brain. At each study site extensive coagulation studies will be performed.
- Conditions
- Hypoxia
- Being tested
- Hypobaric hypoxia
- Keywords
- hypoxia hypobaric
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypobaric hypoxiaOther
Subjects are exposed to hypobaric hypoxia in the context of a high altitude expedition.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | A total of 44 healthy and trained volunteers, age between 18 and 70 years. Subjects must have basic mountaineering experience. Receives: Other: Hypobaric hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary adaption to hypoxia
Measured: Time of reaching 4 different altitudes, expected to be after 1 month
Secondary outcomes (3)
Cerebral adaption to hypoxia
Measured: Time of reaching 4 different altitudes, expected to be after 1 month
Cardiovascular adaption to hypoxia
Measured: Time of reaching 4 different altitudes, expected to be after 1 month
Adaption of the coagulation system
Measured: Time of reaching 4 different altitudes, expected to be after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias M Merz, MD, Principal investigator, Department of Intensive Care Medicine, University Hospital Bern, Switerzland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953198
- Sponsor's protocol ID
- 226/12
- Acronym
- HiReach 2013
- Status last verified
- Sep 2013
- First submitted
- 25 Sep 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Guerci P, Ince C, Dilken O, Belveyre T, Lapoix C, Montomoli J, Hilty MP. Improved Detection of Capillaries in High-Resolution Handheld Vital Microscopy by Use of the MicroTools Advanced Computer Vision Algorithm. Microcirculation. 2026 Jan;33(1):e70045. doi: 10.1111/micc.70045.
PubMed 41485226
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Altitude Medical Research Expedition Himlung 2013 - an Observational Cohort Study of Human Adaption to Hypobaric Hypoxia
- ClinicalTrials.gov ID
- NCT01953198
- Acronym / sponsor ID
- HiReach 2013 / 226/12
- Conditions
- Hypoxia
- Keywords
- hypoxia hypobaric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Sep 2013 (estimated)
- 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 aim of the project "High Altitude Medical Research Expedition Himlung 2013" (HiReach2013) is to comprehensively investigate the cerebral, cardiovascular and pulmonary adaptation and the reactions of the human immune system during an ascent to extreme altitudes of over 7000 m. A total of 44 healthy and trained volunteers will be included in the study after written informed consent has been obtained.Baseline sea level clinical examination will be performed in Bern, Switzerland (BE1) at 550 m 8 to 4 weeks before departure. High altitude research facilities will be available at the altitudes of 5000m, 6100m and 6900m. Post-expedition examination will be performed within 2 to 6 weeks after the end of the expedition in Bern. In the context of 3 sub-projects specific measurements and examinations are performed.
These include: cMRI before and after the climb and neurovascular doppler examination during the climb; blood sampling for coagulation studies, cardiac and thoracic ultrasound, stress tests for assessment of cardiovascular performance.
Detailed description
Background
Altitude related medical problems are gaining more importance and attention as an ever increasing number of people travel to higher altitudes for work or pleasure. Resort towns in Europe and the Western United States at elevations in the 2000 m to 3000 m range attract millions of visitors annually. Many more visit cities in South America and Asia situated above 3000 m. In addition, tens of thousands of travelers, trekkers, and skiers worldwide ascend to elevations in the range of 3000 to 5500 m. An ever-increasing number of recreational climbers attempt ascents of summits of very high (3500 m to 5500 m) or extreme (>5500 m) altitudes. The Nepalese Ministry of Tourism and Civil Aviation and the Nepal Mountaineering Association reported having issued permits to 6032 climbers for peaks higher than 6000 m in the year 2010 alone. When considering that the number of people residing at high altitude is bound to increase, it is of importance to further deepen our understanding of the physiologic changes and dangers associated with exposure to high altitude. Oxygen homeostasis is essential for survival of healthy humans at high altitudes. Various physiological changes involving different organ systems occur during exposition and acclimatization to hypobaric hypoxia in the context of a high altitude sojourn. These include marked adaptations of pulmonary and systemic vascular function, changes in cerebral perfusion and metabolism, physiologic and metabolic adaptations of the immune system and innate defense mechanisms against infection. These changes are a consequence of tissue hypoxia per se or can be mediated by hypoxia induced activation of sympathoadrenal pathways. An example of important research activities in recent years is the discovery of hypoxia-inducible factor 1 alpha (HIF1α) and its role in oxygen homoeostasis by regulation of multiple gene loci. Additionally, as a result of hypoxia induced increase in oxidative/reductive stress, enhanced generation of reactive oxygen (ROS) and nitrogen species (RNS), altered activity of antioxidant systems, and related oxidative damage to lipids, proteins, and DNA can occur as well as injury at the cellular, sub-cellular and molecular levels. These short-lived intermediates include among others superoxide anion (O2), hydrogen peroxide (H2O2), and hypochloride (HOCI. In addition, hydroxyl radicals (OH), hydroxide ions (OH) and superoxide radicals (O2-) are highly reactive members of the ROS family that accumulate under certain physiological and pathophysiological conditions. As a consequence, prolonged hypobaric hypoxia leads to systemic oxidative stress similar to severe inflammation.
Tissue hypoxia and increased oxidative stress as well as adaptive or reactive changes in sympathoadrenal and neuroendocrine processes also occur in various disease states. Hypoxia per se plays an important role in the pathogenesis of major causes of mortality, including cancer, cerebral and myocardial ischemia, and chronic heart and lung disease. Global hypoxemia is a common problem in critically ill patients: In patients with pulmonary failure profound hypoxia can occur due to ventilation/perfusion mismatch or impaired diffusion capacity across the alveolo-capillary membrane despite best medical support including mechanical ventilation. Oxygen delivery to tissues might also be impaired due to low cardiac output or reduced oxygen carrying capacity in anemia. Microcirculatory dysfunction - occurring in the context of severe sepsis - can lead to local hypoxia on a cellular level even in patients with normal or increased arterial oxygen content and oxygen delivery.
In critically ill patients cellular hypoxia induces oxidative stress which can deplete cellular antioxidative capacities and lead to impaired ability to use available oxygen. Depleted levels of reduced glutathione, an important intra-mitochondrial antioxidant, in combination with increased generation of ROS and RNS seem to inhibit oxidative phosphorylation and ATP generation. There is increasing interest in ROS-intermediates and their role in the progression and modulation of vascular dysfunction and remodelling seen in different chronic disease entities, such as diabetes mellitus, chronic heart failure or chronic obstructive pulmonary disease (COPD) and development of pulmonary hypertension (PHT). The mechanisms of ROS-generation are not fully understood. ROS are produced in leukocytes, but the generation of ROS might also occur through disruption of the electron transport chain in mitochondria. The resulting mitochondrial dysfunction has been described as an additional factor causing pulmonary vasoconstriction and remodelling in PHT. In hypoxic patients with respiratory failure an increase of pulmonary vascular pressure frequently occurs (WHO Class III - pulmonary hypertension) which may worsen hypoxemia by impairing lung perfusion. If this increase is caused by a direct vasoconstrictive effect of hypoxia on the pulmonary endothelial cells or by an increase in ROS is still not fully understood.
Generally, the mechanisms leading to adaptation to prolonged hypoxic conditions in healthy humans and in critically ill patients are not well understood. In the context of critical illness these mechanisms are difficult to explore due to the heterogeneity of patients and precipitating illnesses. Furthermore, effects of hypoxia and concurring disease related processes are difficult or impossible to distinguish. Animal models of critical illness might have substantial limitations and often do not represent the human patient. It has been suggested that the physiological and pathophysiological responses to hypobaric hypoxia may be similar to responses seen in critical illness. In the context of a high altitude expedition human subjects can safely be submitted to prolonged hypoxia and oxidative stress and the resulting cerebral, cardiovascular and pulmonary adaptation and changes in mitochondrial function, inflammatory cascade, and coagulatory activity can be explored in a controlled fashion. The study of human responses to hypoxia occurring in a hypobaric environment in healthy volunteers ascending to high altitudes may therefore serve as a model of isolated hypoxia and might help to improve our understanding of the effects in critically ill patients.
Objective
The aim of the project "High Altitude Medical Research Expedition Himlung 2013" (HiReach2013) is to comprehensively investigate the cerebral, cardiovascular and pulmonary adaptation and the reactions of the human coagulation system during an ascent to extreme altitudes of over 7000 m.
Methods
Cardiopulmonary exercise testing will be done using a testing system on a bicycle using a roller trainer for standardization and regulation of the work load. Static and dynamic lung volumes will be assessed at each study site. The measurements will include the assessment DLCO using a commercially available spirometer. Transthoracic Doppler echocardiography will be performed for assessment of systolic/diastolic cardiac function and pulmonary artery pressures. Lung ultrasound will be applied in each subject at each study site to quantify extravascular lung water by ultrasound lung comets. Microparticle measurements will be performed using an Annexin V based ELISA. Cerebral blood flow velocity will be measured from a middle cerebral artery using transcranial Doppler. Structural cerebral changes and cerebral volume will be assessed with MRI of the brain. At each study site extensive coagulation studies will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Other: Hypobaric hypoxiaA total of 44 healthy and trained volunteers, age between 18 and 70 years. Subjects must have basic mountaineering experience. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy and trained volunteers with basic mountaineering experience
Key inclusion criteria (2 listed)
- Subjects must be healthy, well trained and have basic mountaineering experience
- Written informed consent
Key exclusion criteria (5 listed)
- Subjects with any type of cardiac and or respiratory disease
- Subjects with diabetes mellitus type I or II
- Regular intake of beta-blockers, ACE-inhibitors, nitrates and calcium antagonists as well as corticosteroids or anti-inflammatory medication
- Subjects who developed high altitude pulmonary edema after a rapid ascent (< 3 nights) at altitudes below 3500m
- Subjects who developed severe acute mountain sickness and/or high altitude cerebral edema after rapid ascent to altitudes below 3500m
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 |
|---|---|---|
| Hypobaric hypoxiaSubjects are exposed to hypobaric hypoxia in the context of a high altitude expedition. | Other | All study participants |
Primary outcome
Pulmonary adaption to hypoxia
Time frame: Time of reaching 4 different altitudes, expected to be after 1 month
3 secondary outcomes
Cerebral adaption to hypoxia
Time frame: Time of reaching 4 different altitudes, expected to be after 1 month
Cardiovascular adaption to hypoxia
Time frame: Time of reaching 4 different altitudes, expected to be after 1 month
Adaption of the coagulation system
Time frame: Time of reaching 4 different altitudes, expected to be after 1 month
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 30 Sep 2013.
- Derived from this study: PubMed 41485226Guerci P, Ince C, Dilken O, Belveyre T, Lapoix C, Montomoli J, Hilty MP. Improved Detection of Capillaries in High-Resolution Handheld Vital Microscopy by Use of the MicroTools Advanced Computer Vision Algorithm. Microcirculation. 2026 Jan;33(1):e70045. doi: 10.1111/micc.70045.
Related trials for Hypoxia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
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.
Tobias M Merz, MD principal investigator
Department of Intensive Care Medicine, University Hospital Bern, Switerzland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by Insel Gruppe AG, University Hospital Bern 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 2 inclusion and 5 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 30 Sep 2013. 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?
Pulmonary adaption to hypoxia (time frame: Time of reaching 4 different altitudes, expected to be after 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01953198, which also lists 1 linked publication.
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 30 Sep 2013.