Training in Hypoxia to Prevent Acute Mountain Sickness

NCT ID: NCT00886912

Last Updated: 2010-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Mountain Sickness Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypoxia

training in simulated altitude

Group Type ACTIVE_COMPARATOR

hypoxia

Intervention Type OTHER

training in simulated altitude in a hypoxic chamber (normobaric hypoxia)

Normoxia

training under normoxic conditions

Group Type PLACEBO_COMPARATOR

normoxia

Intervention Type OTHER

training under normoxic conditions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hypoxia

training in simulated altitude in a hypoxic chamber (normobaric hypoxia)

Intervention Type OTHER

normoxia

training under normoxic conditions

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy
* non-smoker
* endurance training min. 2x/week

Exclusion Criteria

* any diseases
* previous exposure to altitudes higher than 2000m (last 6 weeks)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Heidelberg

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kai Schommer, MD

Role: PRINCIPAL_INVESTIGATOR

Departement of Sports Medicine, University of Heidelberg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Departement of Sports Medicine, University of Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kai Schommer, MD

Role: CONTACT

+496221568256

Peter Baertsch, MD

Role: CONTACT

+496221568101

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kai Schommer, MD

Role: primary

+49 (0)6221 568256

Peter Bärtsch, MD

Role: backup

+49 (0)6221 268101

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S-160/2008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hyperbaric VO2max Study
NCT02356900 TERMINATED PHASE2