Prevention of Acute Mountain Sickness by Intermittent Hypoxia

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00559832

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Mountain Sickness	Other: Hypoxic Exposure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2006

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Normoxia Sleeping in normoxia for 14 nights prior to one night at 4500 m
Experimental: Hypoxia Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m	Other: Hypoxic Exposure Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m

Arm

Intervention/Treatment

No Intervention: Normoxia

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

Experimental: Hypoxia

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

Other: Hypoxic Exposure

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Sleep quality [during one night at altitude]
ventilatory acclimatization [during one night at altitude]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sports Medicine, University Hospital	Heidelberg		Germany	69120

Sponsors and Collaborators

Heidelberg University

Investigators

Principal Investigator: Christoph Dehnert, MD, University Hospital Heidelberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00559832

Other Study ID Numbers:

039/2006

First Posted:

Nov 16, 2007

Last Update Posted:

Nov 16, 2007

Last Verified:

Nov 1, 2007

Keywords provided by , ,

acute mountain sickness

intermittent hypoxia

acclimatization

Additional relevant MeSH terms:

Altitude Sickness

Hypoxia

Study Results

No Results Posted as of Nov 16, 2007