Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBiALP - Alpine, Disaster and Wilderness Medicine

About this trial

This pilot study aims to evaluate the efficacy of positive expiratory pressure (PEP) therapy at 10 cmH₂O in improving peripheral oxygen saturation (SpO₂) and mitigating symptoms of acute mountain sickness (AMS) in healthy individuals exposed to extreme altitude conditions.

Three male participants will be monitored during an ascent of Mount Aconcagua, Argentina, at elevations of 4,300 m, 5,560 m, and 6,000 m above sea level. The study involves three sequential phases of 10 minutes each: baseline breathing without PEP, breathing with PEP applied via a mechanical face mask, and post-PEP breathing.

Primary outcomes include changes in SpO₂ and Lake Louise Score (LLS) to assess AMS severity. Findings will provide preliminary data on the potential role of PEP as a non-pharmacological intervention in high-altitude medicine.

Eligibility criteria

Qualifiers

Healthy volunteers without ongoing medical conditions

Over 18 years of age

Volunteers with the physical and technical skills necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina, and with previous experience at extreme altitudes

Disqualifiers

Subjects with any ongoing medical conditions

Under 18 years of age

Subjects without previous mountaineering experience at extreme altitudes and without adequate physical and technical preparation necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina

Trial design

Treatments tested in this trial

  • Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia

Treatment groups

3 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

BiALP - Alpine, Disaster and Wilderness Medicine

Lead sponsor

Società Italiana Medicina degli Ambienti Estremi

Collaborator