Acute Mountain SicknessNCT00886912
Training in Hypoxia to Prevent Acute Mountain Sickness
A study testing hypoxia and normoxia in people with Acute Mountain Sickness and Healthy, run by Heidelberg University at 1 site in Germany.
Trial summary
Some studies suggest that high-altitude related illnesses - like acute mountain sickness - could be prevented by acclimatisation, reached at low altitude using training in simulated altitude. The purpose of this study is to determine whether training in hypoxia is suitable to prevent acute mountain sickness. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness, Healthy
- What is being tested?
- hypoxia and normoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Oct 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-smoker
- endurance training min. 2x/week
Who cannot join
- any diseases
- previous exposure to altitudes higher than 2000m (last 6 weeks)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Departement of Sports Medicine, University of Heidelberg
Heidelberg, 69120
Kai Schommer, MD, +49 (0)6221 568256, kai.schommer@med.uni-heidelberg.de
Peter Bärtsch, MD, +49 (0)6221 268101, peter.baertsch@med.uni-heidelberg.de
About this study
Official title: Prevention of Acute Mountain Sickness (AMS) by Intermittent Hypoxic Training
Some studies suggest that high-altitude related illnesses - like acute mountain sickness - could be prevented by acclimatisation, reached at low altitude using training in simulated altitude. The purpose of this study is to determine whether training in hypoxia is suitable to prevent acute mountain sickness.
Read the detailed description
In a three week-period, healthy probands undergo 3 times a week a bicycle ergometer training in simulated altitude followed by 1 week passive exposure at simulated low altitude. 5 days after last exposure, a field study starts performing a rapid ascent to the Capanna Regina Margherita (4559m). Acute mountain sickness is assessed by established scoring systems.
- Conditions
- Acute Mountain Sickness, Healthy
- Being tested
- hypoxia, normoxia
- Keywords
- mountain sickness
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoxiaOther
training in simulated altitude in a hypoxic chamber (normobaric hypoxia)
normoxiaOther
training under normoxic conditions
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia | Active comparator | training in simulated altitude Receives: Other: hypoxia |
| Normoxia | Placebo comparator | training under normoxic conditions Receives: Other: normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute mountain sickness
Measured: after 20 hours at 4559m
Secondary outcomes (1)
Severity of acute mountain sickness
Measured: after 20 hours at 4559m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Kai Schommer, MD, Principal investigator, Departement of Sports Medicine, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886912
- Sponsor's protocol ID
- S-160/2008
- Status last verified
- Apr 2009
- First submitted
- 21 Apr 2009
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Acute Mountain Sickness (AMS) by Intermittent Hypoxic Training
- ClinicalTrials.gov ID
- NCT00886912
- Acronym / sponsor ID
- S-160/2008
- Conditions
- Acute Mountain Sickness, Healthy
- Keywords
- mountain sickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2009 (estimated)
- First posted
- 23 Apr 2009 (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.
Some studies suggest that high-altitude related illnesses - like acute mountain sickness - could be prevented by acclimatisation, reached at low altitude using training in simulated altitude. The purpose of this study is to determine whether training in hypoxia is suitable to prevent acute mountain sickness.
Detailed description
In a three week-period, healthy probands undergo 3 times a week a bicycle ergometer training in simulated altitude followed by 1 week passive exposure at simulated low altitude. 5 days after last exposure, a field study starts performing a rapid ascent to the Capanna Regina Margherita (4559m). Acute mountain sickness is assessed by established scoring systems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | Active comparator | Other: hypoxiatraining in simulated altitude |
| Normoxia | Placebo comparator | Other: normoxiatraining under normoxic conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- non-smoker
- endurance training min. 2x/week
Key exclusion criteria (2 listed)
- any diseases
- previous exposure to altitudes higher than 2000m (last 6 weeks)
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 |
|---|---|---|
| hypoxiatraining in simulated altitude in a hypoxic chamber (normobaric hypoxia) | Other | Hypoxia |
| normoxiatraining under normoxic conditions | Other | Normoxia |
Primary outcome
Incidence of acute mountain sickness
Time frame: after 20 hours at 4559m
1 secondary outcome
Severity of acute mountain sickness
Time frame: after 20 hours at 4559m
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
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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.
Kai Schommer, MD principal investigator
Departement of Sports Medicine, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypoxia and normoxia in people with Acute Mountain Sickness and Healthy, run by Heidelberg University at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Jun 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Schommer, MD (+496221568256, kai.schommer@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute mountain sickness (time frame: after 20 hours at 4559m). 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 25 Jun 2010.