Alternative Treatments in Acute Mountain Sickness (TAIA)

Institut de Formation et de Recherche en Médecine de Montagne

Status: Terminated

Conditions: Acute Mountain Sickness

Treatments: Other: Fake Osteopathic protocol; Device: PEEP 10cmH2O; Other: PEEP-Sham; Procedure: Osteopathic protocol for improving drainage of LCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03956472

TAIA

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Experienced alpinist
• No previous acclimatization

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 3 patient groups

Osteopathic group

Experimental group

Description:

LCS Drainage before altitude exposure

Treatment:

Other: PEEP-Sham

Procedure: Osteopathic protocol for improving drainage of LCS

PEEP 10 cmH2O

Experimental group

Description:

10 min at rest

Treatment:

Other: Fake Osteopathic protocol

Device: PEEP 10cmH2O

Control group

Sham Comparator group

Description:

Sham PEEP and fake osteopathic protocol

Treatment:

Other: PEEP-Sham

Other: Fake Osteopathic protocol