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Alternative Treatments in Acute Mountain Sickness

NCT03956472 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-08-30

No results posted yet for this study

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.

Conditions

  • Acute Mountain Sickness

Interventions

PROCEDURE

Osteopathic protocol for improving drainage of LCS

Osteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation

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

OTHER

PEEP-Sham

PEEP 0 cmH2O (hidden)

Sponsors & Collaborators

  • Institut de Formation et de Recherche en Médecine de Montagne

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-17
Primary Completion
2018-10-20
Completion
2019-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03956472 on ClinicalTrials.gov