Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID) (SLEEP-AID)
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|ClinicalTrials.gov Identifier: NCT01842906|
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : April 20, 2017
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Mountain Sickness||Device: Theravent Device: Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial for Assessment of a Novel Non-Pharmacologic Intervention for Decrease in Altitude Illness|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||October 2014|
A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
nasal EPAP device
Sham Comparator: Control
A visibly identical sham device that does not provide positive end expiratory pressure.
Sham device without EPAP
- Incidence of Acute Mountain Sickness [ Time Frame: Approximately 10 hours ]Acute mountain sickness will be measured by Lake Louise Criteria and diagnosed as LLC > or = to 3 with presence of a headache. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.
- Number of Nocturnal Desaturations [ Time Frame: Approximately 10 hours ]Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.
- Acute Mountain Sickness Severity [ Time Frame: approximately 10 hours ]Severity of acute mountain sickness will be evaluated by the Lake Louise Criteria (0-15 point scale) with higher scores representing more severe symptoms. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.
- Nocturnal Awakenings [ Time Frame: approximately 10 hours ]Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842906
|Pheriche & Dingboche, Khumbu, Nepal|
|Principal Investigator:||Grant S Lipman, MD||Stanford University|