Alternative Treatments in Acute Mountain Sickness (TAIA)

August 24, 2021 updated by: Hugo Nespoulet, Institut de Formation et de Recherche en Médecine de Montagne

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Chamonix, France, 74400
        • Ifremmont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Experienced alpinist
  • No previous acclimatization

Exclusion Criteria:

  • Heart failure, respiratory failure, kidney failure
  • Pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Lake Louise Score from baseline to altitude continuous exposure.
Time Frame: mesured and reported every hour during a 10 hours altitude 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.
Time Frame: every hour during a 10 hours altitude 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Formation et de Recherche en Médecine de Montagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2017

Primary Completion (Actual)

October 20, 2018

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAIA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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