NCT00886912

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

June 25, 2010

Status Verified

April 1, 2009

Enrollment Period

2 months

First QC Date

April 21, 2009

Last Update Submit

June 24, 2010

Conditions

Acute Mountain SicknessHealthy

Keywords

mountain sickness

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute mountain sickness

    after 20 hours at 4559m

Secondary Outcomes (1)

  • Severity of acute mountain sickness

    after 20 hours at 4559m

Study Arms (2)

Hypoxia

ACTIVE COMPARATOR

training in simulated altitude

Other: hypoxia

Normoxia

PLACEBO COMPARATOR

training under normoxic conditions

Other: normoxia

Interventions

hypoxiaOTHER

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

Hypoxia
normoxiaOTHER

training under normoxic conditions

Normoxia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Sports Medicine, University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Kai Schommer, MD

    Departement of Sports Medicine, University of Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Schommer, MD

CONTACT

+496221568256kai.schommer@med.uni-heidelberg.de

Peter Baertsch, MD

CONTACT

+496221568101peter_baertsch@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

October 1, 2009

Last Updated

June 25, 2010

Record last verified: 2009-04

Locations

DE(1)