Alternative Treatments in Acute Mountain Sickness

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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

, , 


Verification Date

May 2019