[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604373":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":31,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":20,"eligibilityCriteria":41,"healthyVolunteers":42,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":20,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":20,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"BiALP - Alpine, Disaster and Wilderness Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Pilot trial of positive expiratory pressure for acute mountain sickness.\n\n1 single arm with 3 phases:\n\n* 1: Baseline Breathing (No PEP) Participants breathe normally without any device for 10 minutes in supine position, serving as control.\n* 2: Positive Expiratory Pressure (PEP) Breathing Participants breathe through a face mask with a mechanical PEP device set at 10 cmH₂O expiratory pressure for 10 minutes supine. Inspiration is unrestricted; expiration occurs against resistance to improve oxygenation and reduce AMS symptoms.\n* 3: Post-PEP Breathing (No PEP) After PEP, participants breathe normally for 10 minutes supine.\n\nEach phase is consecutive at altitudes 4,300 m, 5,560 m, and 6,000 m",[13],"Device: Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","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.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Paolo Rodi, MD","CONTACT","+41766992164","paolorodi95@gmail.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Paolo Rodi","MD, MScMD, principal investigator",[32],{"name":33,"class":34},"Società Italiana Medicina degli Ambienti Estremi","UNKNOWN","100604373","efficacy-of-positive-expiratory-pressure-on-acute-mountain-sickness-100604373",false,"NCT07148674","Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness","Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness, a Pilot Crossover Trial at 6000 Meters","Inclusion Criteria:\n\n* Healthy volunteers without ongoing medical conditions\n* Over 18 years of age\n* Volunteers with the physical and technical skills necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina, and with previous experience at extreme altitudes\n\nExclusion Criteria:\n\n* Subjects with any ongoing medical conditions\n* Under 18 years of age\n* 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",true,"ALL","18 Years","99 Years",{"count":47,"type":48},3,"ESTIMATED","INTERVENTIONAL",[51],"NA","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.\n\nThree 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.\n\nPrimary 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.",[54],"Acute Mountain Sickness (AMS)","NOT_YET_RECRUITING","2025-08-28",{"date":58,"type":59},"2025-08-29","ACTUAL",{"date":61,"type":48},"2025-09-05",{"date":63,"type":48},"2025-12-31",{"name":5,"class":6}]