Clinical Trials Directory

Trials / Terminated

TerminatedNCT03956472

Alternative Treatments in Acute Mountain Sickness

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Institut de Formation et de Recherche en Médecine de Montagne · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREOsteopathic protocol for improving drainage of LCSOsteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation
DEVICEPEEP 10cmH2OBreathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high
OTHERFake Osteopathic protocolPlacebo intervention
OTHERPEEP-ShamPEEP 0 cmH2O (hidden)

Timeline

Start date
2017-06-17
Primary completion
2018-10-20
Completion
2019-07-31
First posted
2019-05-20
Last updated
2021-08-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03956472. Inclusion in this directory is not an endorsement.