Alternative Treatments in Acute Mountain Sickness

Study Overview
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Brief Summary
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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.

Official Title
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Can Osteopathy and Expiratory Resistance be Used in Prevention and/or Treatment of Acute Mountain Sickness ? a Randomized Controlled Field Study

Conditions
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Acute Mountain Sickness

Intervention / Treatment
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* Procedure: Osteopathic protocol for improving drainage of LCS
* Device: PEEP 10cmH2O
* Other: Fake Osteopathic protocol
* Other: PEEP-Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Experienced alpinist No previous acclimatization Exclusion Criteria: Heart failure, respiratory failure, kidney failure Pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic group<br>LCS Drainage before altitude exposure | Procedure: Osteopathic protocol for improving drainage of LCS<br>* Osteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation<br>Other: PEEP-Sham<br>* PEEP 0 cmH2O (hidden)<br>|
| Experimental: PEEP 10 cmH2O<br>10 min at rest | Device: PEEP 10cmH2O<br>* Breathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high<br>Other: Fake Osteopathic protocol<br>* Placebo intervention<br>|
| Sham Comparator: Control group<br>Sham PEEP and fake osteopathic protocol | Other: Fake Osteopathic protocol<br>* Placebo intervention<br>Other: PEEP-Sham<br>* PEEP 0 cmH2O (hidden)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Lake Louise Score from baseline to altitude continuous exposure. | Signs of acute mountain sickness regarding its severity according the official Lake Louise Score. | mesured and reported every hour during a 10 hours altitude exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in numeric scale of well being from baseline to altitude continuous exposure. | Quantification of general feeling on a scale from 0 (feeling as before ascent) to 10 (worst feeling) | every hour during a 10 hours altitude exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Altitude, Acute mountain sickness, Osteopathy, End expiratory pressure