Alternative Treatments in Acute Mountain Sickness

Not Applicable

Terminated

• Conditions: Acute Mountain Sickness
• Interventions: Procedure: Osteopathic protocol for improving drainage of LCS; Device: PEEP 10cmH2O; Other: PEEP-Sham; Other: Fake Osteopathic protocol

• Registration Number: NCT03956472
• Lead Sponsor: Institut de Formation et de Recherche en Médecine de Montagne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-16
• Study Start: 2017-06-17
• Primary Completion: 2018-10-20
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Completion: 2019-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy
• Experienced alpinist
• No previous acclimatization

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathic group	PEEP-Sham	LCS Drainage before altitude exposure
Osteopathic group	Osteopathic protocol for improving drainage of LCS	LCS Drainage before altitude exposure
PEEP 10 cmH2O	PEEP 10cmH2O	10 min at rest
PEEP 10 cmH2O	Fake Osteopathic protocol	10 min at rest
Control group	Fake Osteopathic protocol	Sham PEEP and fake osteopathic protocol
Control group	PEEP-Sham	Sham PEEP and fake osteopathic protocol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Ifremmont; 🇫🇷 Chamonix, France