Prevention of Acute Mountain Sickness by Intermittent Hypoxia - Tabular View

Tracking Information

First Received Date ^ICMJE

November 15, 2007

Last Updated Date

November 15, 2007

Start Date ^ICMJE

March 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

incidence of acute mountain sickness [ Time Frame: during one night at 4500 m ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Sleep quality [ Time Frame: during one night at altitude ]
ventilatory acclimatization [ Time Frame: during one night at altitude ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Prevention of Acute Mountain Sickness by Intermittent Hypoxia

Official Title ^ICMJE

Prevention of Acute Mountain Sickness by Sleeping at Simulated Altitude (Normobaric Hypoxia)

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Acute Mountain Sickness

Intervention ^ICMJE

Other: Hypoxic Exposure

Study Arms / Comparison Groups

No Intervention: Sleeping in normoxia for 14 nights prior to one night at 4500 m
Experimental: Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

healthy

Exclusion Criteria:

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

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00559832

Responsible Party

Study ID Numbers ^ICMJE

039/2006

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christoph Dehnert, MD

University Hospital Heidelberg

Information Provided By

University of Heidelberg

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP