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Prevention of Acute Mountain Sickness by Intermittent Hypoxia

NCT ID: NCT00559832

Last Updated: 2007-11-16

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-07-31

Brief Summary

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Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective in prevention of acute mountain sickness (AMS).

The aim of this study is to investigate whether intermittent exposure to normobaric hypoxia during sleep is also effective to prevent AMS.

Detailed Description

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Conditions

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Acute Mountain Sickness

Keywords

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acute mountain sickness intermittent hypoxia acclimatization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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Normoxia

Sleeping in normoxia for 14 nights prior to one night at 4500 m

Group Type NO_INTERVENTION

No interventions assigned to this group

Hypoxia

Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m

Group Type EXPERIMENTAL

Hypoxic Exposure

Intervention Type OTHER

Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m

Interventions

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Hypoxic Exposure

Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy

Exclusion Criteria

* Altitude exposure above 2000 m 8 weeks prior or during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Christoph Dehnert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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Sports Medicine, University Hospital

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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039/2006

Identifier Type: -

Identifier Source: org_study_id