Brief Title
Alternative Treatments in Acute Mountain Sickness
Official Title
Can Osteopathy and Expiratory Resistance be Used in Prevention and/or Treatment of Acute Mountain Sickness ? a Randomized Controlled Field Study
Brief Summary
The purpose of this research is to support a hypothesis that osteopathic manual medicine (OMM) and / or a 10 cmH2O end-expiratory pressure (PEEP) could be used in the prevention of acute mountain sickness (AMS). During altitude exposure, an exaggerated hypoxemia and the increase of intracranial pressure are both known to be major physipathological ways of AMS development. The goal of the osteopathic protocol is to release tension on the circulatory structures directly related to cranial circulation and drainage. The main hypothesis is that it could lead to lower intracranial pressure and help reducing AMS signs. Furthermore the investigators would like to define a osteopathic score for individual AMS sensitivity, based on cranial bones mobility. Several studies have shown that using PEEP at altitude (or hypoxia) increases SpO2. As for osteopathy protocol, the investigators would like to apply this experimental condition during real altitude exposure in a randomized controlled protocol.
Study Type
Interventional
Primary Outcome
Changes in Lake Louise Score from baseline to altitude continuous exposure.
Secondary Outcome
Changes in numeric scale of well being from baseline to altitude continuous exposure.
Condition
Acute Mountain Sickness
Intervention
Osteopathic protocol for improving drainage of LCS
Study Arms / Comparison Groups
Osteopathic group
Description: LCS Drainage before altitude exposure
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
Procedure
Estimated Enrollment
50
Start Date
June 17, 2017
Completion Date
July 31, 2019
Primary Completion Date
October 20, 2018
Eligibility Criteria
Inclusion Criteria: - Healthy - Experienced alpinist - No previous acclimatization Exclusion Criteria: - Heart failure, respiratory failure, kidney failure - Pregnant woman
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03956472
Organization ID
TAIA
Responsible Party
Principal Investigator
Study Sponsor
Institut de Formation et de Recherche en Médecine de Montagne
Study Sponsor
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Verification Date
August 2021