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
Locations
Sponsors and collaborators
BiALP - Alpine, Disaster and Wilderness Medicine
Lead sponsor
Società Italiana Medicina degli Ambienti Estremi
Collaborator