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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03956472

Acronym

TAIA

Enrollment

Registered

2019-05-20

Start date

2017-06-17

Completion date

2019-07-31

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Mountain Sickness

Keywords

Altitude, Acute mountain sickness, Osteopathy, End expiratory pressure

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.

Interventions

PROCEDUREOsteopathic protocol for improving drainage of LCS

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

DEVICEPEEP 10cmH2O

Breathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high

OTHERFake Osteopathic protocol

Placebo intervention

OTHERPEEP-Sham

PEEP 0 cmH2O (hidden)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy * Experienced alpinist * No previous acclimatization

Exclusion criteria

* Heart failure, respiratory failure, kidney failure * Pregnant woman

Design outcomes

Primary

Measure	Time frame	Description
Changes in Lake Louise Score from baseline to altitude continuous exposure.	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.

Secondary

Measure	Time frame	Description
Changes in numeric scale of well being from baseline to altitude continuous exposure.	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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026