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Training in Hypoxia to Prevent Acute Mountain Sickness

Primary Purpose

Acute Mountain Sickness, Healthy

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

hypoxia

normoxia

About this trial

This is an interventional prevention trial for Acute Mountain Sickness focused on measuring mountain sickness

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

any diseases
previous exposure to altitudes higher than 2000m (last 6 weeks)

Sites / Locations

Departement of Sports Medicine, University of HeidelbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hypoxia

Normoxia

Arm Description

training in simulated altitude

training under normoxic conditions

Outcomes

Primary Outcome Measures

Incidence of acute mountain sickness

Secondary Outcome Measures

Severity of acute mountain sickness

Full Information

NCT ID

NCT00886912

First Posted

April 21, 2009

Last Updated

June 24, 2010

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00886912

Brief Title

Training in Hypoxia to Prevent Acute Mountain Sickness

Official Title

Prevention of Acute Mountain Sickness (AMS) by Intermittent Hypoxic Training

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Mountain Sickness, Healthy

Keywords

mountain sickness

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypoxia

Arm Type

Active Comparator

Arm Description

training in simulated altitude

Arm Title

Normoxia

Arm Type

Placebo Comparator

Arm Description

training under normoxic conditions

Intervention Type

Other

Intervention Name(s)

hypoxia

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

normoxia

Intervention Description

training under normoxic conditions

Primary Outcome Measure Information:

Title

Incidence of acute mountain sickness

Time Frame

after 20 hours at 4559m

Secondary Outcome Measure Information:

Title

Severity of acute mountain sickness

Time Frame

after 20 hours at 4559m

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: healthy non-smoker endurance training min. 2x/week Exclusion Criteria: any diseases previous exposure to altitudes higher than 2000m (last 6 weeks)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kai Schommer, MD

Phone

+496221568256

kai.schommer@med.uni-heidelberg.de

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Baertsch, MD

Phone

+496221568101

peter_baertsch@med.uni-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kai Schommer, MD

Organizational Affiliation

Departement of Sports Medicine, University of Heidelberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Departement of Sports Medicine, University of Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kai Schommer, MD

Phone

+49 (0)6221 568256

kai.schommer@med.uni-heidelberg.de

First Name & Middle Initial & Last Name & Degree

Peter Bärtsch, MD

Phone

+49 (0)6221 268101

peter.baertsch@med.uni-heidelberg.de

12. IPD Sharing Statement

Learn more about this trial

Training in Hypoxia to Prevent Acute Mountain Sickness

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