Trials / Terminated
TerminatedNCT03956472
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Institut de Formation et de Recherche en Médecine de Montagne · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| OTHER | PEEP-Sham | PEEP 0 cmH2O (hidden) |
Timeline
- Start date
- 2017-06-17
- Primary completion
- 2018-10-20
- Completion
- 2019-07-31
- First posted
- 2019-05-20
- Last updated
- 2021-08-30
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03956472. Inclusion in this directory is not an endorsement.