NCT00559832

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
Last Updated

November 16, 2007

Status Verified

November 1, 2007

First QC Date

November 15, 2007

Last Update Submit

November 15, 2007

Conditions

Acute Mountain Sickness

Keywords

acute mountain sicknessintermittent hypoxiaacclimatization

Outcome Measures

Primary Outcomes (1)

  • incidence of acute mountain sickness

    during one night at 4500 m

Secondary Outcomes (2)

  • Sleep quality

    during one night at altitude

  • ventilatory acclimatization

    during one night at altitude

Study Arms (2)

Normoxia

NO INTERVENTION

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

Hypoxia

EXPERIMENTAL

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

Other: Hypoxic Exposure

Interventions

Hypoxic ExposureOTHER

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

Hypoxia

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy

You may not qualify if:

  • Altitude exposure above 2000 m 8 weeks prior or during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Medicine, University Hospital

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Christoph Dehnert, MD

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

March 1, 2006

Study Completion

July 1, 2007

Last Updated

November 16, 2007

Record last verified: 2007-11

Locations

DE(1)