Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness

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.

NCT Number	NCT07148674
Lead Sponsor	BiALP - Alpine, Disaster and Wilderness Medicine Collaborators: Società Italiana Medicina degli Ambienti Estremi
Conditions	Acute Mountain Sickness (AMS)
Enrollment	3 participants
Start Date	2025-09-05
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-29