Clinical Trials Logo

Clinical Trial Summary

The study is examining if an over-the-counter device (Theravent) worn while sleeping can reduce acute mountain sickness upon awakening in a high altitude trekking population.


Clinical Trial Description

The specific aim of this study is to evaluate if an inexpensive and disposable end-expiratory pressure device can prevent acute mountain sickness (AMS). AMS is a common disorder found in 25-75% of hikers and trekkers in N. America and Europe who expediently ascend high altitude (>8,000 ft). This environmental malady is insidious in onset and prevention is necessary not just to limit progression to severe or fatal disease, but also to limit physiologic deterioration in those who seek enjoyment or employment at high altitudes. One of the hallmarks of both healthy and sick individuals sleeping at high altitude is an oscillating pattern of respiration marked by periods of hyperventilation alternating with apnea or hypopnea. This distressing "periodic breathing" pattern leads to a feeling of suffocation, prevents restful sleep, and the hypoxic events may well worsen ensuing AMS. Prior studies have found positive end-expiratory pressure (PEEP) an effective non-pharmacologic method to prevent nocturnal desaturations and decreasing both AMS incidence and severity.

Traditionally, PEEP devices are cumbersome and expensive, and while showing promising efficacy, are limited by both cost and portability as a useful non-pharmacologic option for AMS prophylaxis. The SLEEP-AID methodology is designed to prospectively enroll participants, randomized in a double blind placebo-controlled fashion to either the intervention [Theravent (Ventus Medical) which is single use, inexpensive, and very small] or a visually identical "sham" placebo group, and gather physiologic data to accurately reflect sleep patterns of high altitude travelers and objective as well as subjective outcomes of the intervention. The benefit of this approach will be to provide definitive data in a large and diverse cross section of a real hiking population that is generalizable to the majority of tens of millions of hikers, climbers, and high altitude tourists in the United States, Europe, Asia, and South America. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01842906
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date October 2014

See also
  Status Clinical Trial Phase
Completed NCT04111263 - Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude N/A
Completed NCT01536288 - Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness Phase 2
Completed NCT00326703 - Effects of Aircraft Cabin Altitude on Passenger Comfort and Discomfort N/A
Completed NCT06310642 - Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness Phase 4
Completed NCT03561675 - Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years Phase 4
Completed NCT00559832 - Prevention of Acute Mountain Sickness by Intermittent Hypoxia N/A
Completed NCT01436383 - Oxidative Stress in Hypobaric Hypoxia N/A
Completed NCT00603122 - Acclimatization Mechanisms During Ascent to 7500m N/A
Completed NCT00664001 - Anti-Oxidant Supplementation for the Prevention of Acute Mountain Sickness Phase 3
Completed NCT00627965 - Randomized, Controlled Trial of Regular Sildenafil Citrate in the Prevention of Altitude Illness Phase 4
Not yet recruiting NCT06145113 - The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness N/A
Recruiting NCT05733338 - The Effects of Intermittent Hypoxia on Acute Hypoxic Injury N/A
Completed NCT01522326 - Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness N/A
Recruiting NCT06393998 - CO2 Supplement for Treatment of Acute Mountain Sickness N/A
Completed NCT03270787 - Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness Phase 1/Phase 2
Completed NCT02811016 - Inhaled Budesonide and Acute Mountain Sickness Phase 1
Recruiting NCT00886912 - Training in Hypoxia to Prevent Acute Mountain Sickness N/A
Terminated NCT03956472 - Alternative Treatments in Acute Mountain Sickness N/A
Recruiting NCT03621410 - T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent Phase 2
Active, not recruiting NCT01565603 - Sleep and Cerebral Responses to High Altitude N/A