Alternative Treatments in Acute Mountain Sickness

NCT03956472 | Terminated

• 1 other identifier: TAIA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Mountain Sickness

Keywords

Altitude; Acute mountain sickness; Osteopathy; End expiratory pressure

Outcome Measures

Primary Outcomes (1)

• Changes in Lake Louise Score from baseline to altitude continuous 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 Outcomes (1)

• Changes in numeric scale of well being from baseline to altitude continuous exposure.

  every hour during a 10 hours altitude exposure

Study Arms (3)

Osteopathic group

EXPERIMENTAL

LCS Drainage before altitude exposure

Procedure: Osteopathic protocol for improving drainage of LCS; Other: PEEP-Sham

PEEP 10 cmH2O

EXPERIMENTAL

10 min at rest

Device: PEEP 10cmH2O; Other: Fake Osteopathic protocol

Control group

SHAM COMPARATOR

Sham PEEP and fake osteopathic protocol

Other: Fake Osteopathic protocol; Other: PEEP-Sham

Interventions

Osteopathic protocol for improving drainage of LCS PROCEDURE

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

Osteopathic group

PEEP 10cmH2O DEVICE

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

PEEP 10 cmH2O

Fake Osteopathic protocol OTHER

Placebo intervention

Control group; PEEP 10 cmH2O

PEEP-Sham OTHER

PEEP 0 cmH2O (hidden)

Control group; Osteopathic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• Experienced alpinist
• No previous acclimatization

You may not qualify if:

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

Sponsors & Collaborators

• Institut de Formation et de Recherche en Médecine de Montagne: lead

Study Sites (1)

Ifremmont

Chamonix, 74400, France

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of research

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: May 20, 2019
• Study Start: June 17, 2017
• Primary Completion: October 20, 2018
• Study Completion: July 31, 2019
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

FR (1)