Acute Mountain SicknessNCT00603122
Acclimatization Mechanisms During Ascent to 7500m
A study testing ascent protocol in people with Acute Mountain Sickness, run by University of Zurich.
Trial summary
The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- ascent protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Dec 2005
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, physically fit subject
- Mountaineering experience
Who cannot join
- Any type of cardiac or respiratory disease
- Regular intake of any medication
- History of high altitude pulmonary oedema
- Severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.
About this study
Official title: Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology
The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.
- Conditions
- Acute Mountain Sickness
- Being tested
- ascent protocol
- Keywords
- altitude illness, hypoxia
- Medical subject headings
- Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ascent protocolBehavioural
ascent protocol for the two groups has different acclimatization time
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fast ascent Receives: Behavioral: ascent protocol |
| 2 | Active comparator | slow ascent Receives: Behavioral: ascent protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute mountain sickness
Measured: during ascent
Secondary outcomes (1)
mountaineering success, oxygen saturation, breathing pattern
Measured: during ascent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Investigators
- Konrad E Bloch, MD, Principal investigator, Pulmonary Division, University Hospital of Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603122
- Sponsor's protocol ID
- EK-1189
- Other IDs
- SNSF 3200B0-108300
- Status last verified
- May 2014
- First submitted
- 15 Jan 2008
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bloch KE, Latshang TD, Turk AJ, Hess T, Hefti U, Merz TM, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Schoch OD. Nocturnal periodic breathing during acclimatization at very high altitude at Mount Muztagh Ata (7,546 m). Am J Respir Crit Care Med. 2010 Aug 15;182(4):562-8. doi: 10.1164/rccm.200911-1694OC. Epub 2010 May 4.
PubMed 20442435Garde A, Giraldo BF, Jane R, Latshang TD, Turk AJ, Hess T, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Hefti U, Merz TM, Schoch OD, Bloch KE. Periodic breathing during ascent to extreme altitude quantified by spectral analysis of the respiratory volume signal. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:707-10. doi: 10.1109/EMBC.2012.6346029.
PubMed 23365990Latshang TD, Turk AJ, Hess T, Schoch OD, Bosch MM, Barthelmes D, Merz TM, Hefti U, Hefti JP, Maggiorini M, Bloch KE. Acclimatization improves submaximal exercise economy at 5533 m. Scand J Med Sci Sports. 2013 Aug;23(4):458-67. doi: 10.1111/j.1600-0838.2011.01403.x. Epub 2011 Nov 3.
PubMed 22093058Bloch KE, Turk AJ, Maggiorini M, Hess T, Merz T, Bosch MM, Barthelmes D, Hefti U, Pichler J, Senn O, Schoch OD. Effect of ascent protocol on acute mountain sickness and success at Muztagh Ata, 7546 m. High Alt Med Biol. 2009 Spring;10(1):25-32. doi: 10.1089/ham.2008.1043.
PubMed 19326598
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology
- ClinicalTrials.gov ID
- NCT00603122
- Acronym / sponsor ID
- EK-1189
- Conditions
- Acute Mountain Sickness
- Keywords
- altitude illness, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 28 Jan 2008 (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 trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: ascent protocolfast ascent |
| 2 | Active comparator | Behavioral: ascent protocolslow ascent |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy, physically fit subject
- Mountaineering experience
Key exclusion criteria (4 listed)
- Any type of cardiac or respiratory disease
- Regular intake of any medication
- History of high altitude pulmonary oedema
- Severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.
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 |
|---|---|---|
| ascent protocolascent protocol for the two groups has different acclimatization time | Behavioural | 1, 2 |
Primary outcome
acute mountain sickness
Time frame: during ascent
1 secondary outcome
mountaineering success, oxygen saturation, breathing pattern
Time frame: during ascent
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 20 May 2014.
- Background: PubMed 20442435Bloch KE, Latshang TD, Turk AJ, Hess T, Hefti U, Merz TM, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Schoch OD. Nocturnal periodic breathing during acclimatization at very high altitude at Mount Muztagh Ata (7,546 m). Am J Respir Crit Care Med. 2010 Aug 15;182(4):562-8. doi: 10.1164/rccm.200911-1694OC. Epub 2010 May 4.
- Background: PubMed 23365990Garde A, Giraldo BF, Jane R, Latshang TD, Turk AJ, Hess T, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Hefti U, Merz TM, Schoch OD, Bloch KE. Periodic breathing during ascent to extreme altitude quantified by spectral analysis of the respiratory volume signal. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:707-10. doi: 10.1109/EMBC.2012.6346029.
- Background: PubMed 22093058Latshang TD, Turk AJ, Hess T, Schoch OD, Bosch MM, Barthelmes D, Merz TM, Hefti U, Hefti JP, Maggiorini M, Bloch KE. Acclimatization improves submaximal exercise economy at 5533 m. Scand J Med Sci Sports. 2013 Aug;23(4):458-67. doi: 10.1111/j.1600-0838.2011.01403.x. Epub 2011 Nov 3.
- Results publication: PubMed 19326598Bloch KE, Turk AJ, Maggiorini M, Hess T, Merz T, Bosch MM, Barthelmes D, Hefti U, Pichler J, Senn O, Schoch OD. Effect of ascent protocol on acute mountain sickness and success at Muztagh Ata, 7546 m. High Alt Med Biol. 2009 Spring;10(1):25-32. doi: 10.1089/ham.2008.1043.
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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.
Konrad E Bloch, MD principal investigator
Pulmonary Division, University Hospital of Zurich, Zurich, Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing ascent protocol in people with Acute Mountain Sickness, run by University of Zurich.
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 4 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
acute mountain sickness (time frame: during ascent). 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 NCT00603122, which also lists 4 linked publications.
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 20 May 2014.