Back to resultsAlternative Treatments in Acute Mountain Sickness (TAIA)
Primary Purpose
Acute Mountain Sickness
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathic protocol for improving drainage of LCS
PEEP 10cmH2O
Fake Osteopathic protocol
PEEP-Sham
Sponsored by
About this trial
This is an interventional prevention trial for Acute Mountain Sickness focused on measuring Altitude, Acute mountain sickness, Osteopathy, End expiratory pressure
Eligibility Criteria
Inclusion Criteria:
- Healthy
- Experienced alpinist
- No previous acclimatization
Exclusion Criteria:
- Heart failure, respiratory failure, kidney failure
- Pregnant woman
Sites / Locations
- Ifremmont
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Osteopathic group
PEEP 10 cmH2O
Control group
Arm Description
LCS Drainage before altitude exposure
10 min at rest
Sham PEEP and fake osteopathic protocol
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT03956472
First Posted
November 16, 2016
Last Updated
August 24, 2021
Sponsor
Institut de Formation et de Recherche en Médecine de Montagne
1. Study Identification
Unique Protocol Identification Number
NCT03956472
Brief Title
Alternative Treatments in Acute Mountain Sickness
Acronym
TAIA
Official Title
Can Osteopathy and Expiratory Resistance be Used in Prevention and/or Treatment of Acute Mountain Sickness ? a Randomized Controlled Field Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
End of european funding
Study Start Date
June 17, 2017 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Formation et de Recherche en Médecine de Montagne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness
Keywords
Altitude, Acute mountain sickness, Osteopathy, End expiratory pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osteopathic group
Arm Type
Experimental
Arm Description
LCS Drainage before altitude exposure
Arm Title
PEEP 10 cmH2O
Arm Type
Experimental
Arm Description
10 min at rest
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham PEEP and fake osteopathic protocol
Intervention Type
Procedure
Intervention Name(s)
Osteopathic protocol for improving drainage of LCS
Intervention Description
Osteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation
Intervention Type
Device
Intervention Name(s)
PEEP 10cmH2O
Intervention Description
Breathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high
Intervention Type
Other
Intervention Name(s)
Fake Osteopathic protocol
Intervention Description
Placebo intervention
Intervention Type
Other
Intervention Name(s)
PEEP-Sham
Intervention Description
PEEP 0 cmH2O (hidden)
Primary Outcome Measure Information:
Title
Changes in Lake Louise Score from baseline to altitude continuous exposure.
Description
Signs of acute mountain sickness regarding its severity according the official Lake Louise Score.
Time Frame
mesured and reported every hour during a 10 hours altitude exposure
Secondary Outcome Measure Information:
Title
Changes in numeric scale of well being from baseline to altitude continuous exposure.
Description
Quantification of general feeling on a scale from 0 (feeling as before ascent) to 10 (worst feeling)
Time Frame
every hour during a 10 hours altitude exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Experienced alpinist
No previous acclimatization
Exclusion Criteria:
Heart failure, respiratory failure, kidney failure
Pregnant woman
Facility Information:
Facility Name
Ifremmont
City
Chamonix
ZIP/Postal Code
74400
Country
France
12. IPD Sharing Statement
Learn more about this trial
Alternative Treatments in Acute Mountain Sickness
We'll reach out to this number within 24 hrs