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Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness
Sponsor: BiALP - Alpine, Disaster and Wilderness Medicine
Summary
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.
Official title: Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness, a Pilot Crossover Trial at 6000 Meters
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
3
Start Date
2025-09-05
Completion Date
2025-12-31
Last Updated
2025-08-29
Healthy Volunteers
Yes
Conditions
Interventions
Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia
The intervention under investigation will be the application of positive expiratory pressure (PEP) at 10 cmH₂O using an Ambu mask. The mask will allow participants to inspire freely while generating a controlled expiratory pressure. The PEP device is a non-pharmacological medical device whose uses in both hospital and pre-hospital settings are part of everyday medical practice.