Alternative Treatments in Acute Mountain Sickness

Acute Mountain Sickness Clinical Trial

— TAIA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03956472
• Other study ID #: TAIA
• Status: Terminated
• Phase: N/A
• Start date: June 17, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2021
• Source: Institut de Formation et de Recherche en Médecine de Montagne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: July 31, 2019
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy
• Experienced alpinist
• No previous acclimatization

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

Intervention

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
• PEEP-Sham
PEEP 0 cmH2O (hidden)

Locations

Country	Name	City	State
France	Ifremmont	Chamonix

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Formation et de Recherche en Médecine de Montagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in numeric scale of well being from baseline to altitude continuous exposure.	Quantification of general feeling on a scale from 0 (feeling as before ascent) to 10 (worst feeling)	every hour during a 10 hours altitude exposure