Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial for Assessment of a Novel Non-Pharmacologic Intervention for Decrease in Altitude Illness

Conditions
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Acute Mountain Sickness

Intervention / Treatment
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* Device: Theravent
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 18-65 Lake Louise Score (LLS) of < 3 Have not taken NSAIDs, acetazolamide, or corticosteroids in the prior week Have not traveled above 4200 m in the prior week. First night in Pheriche or Dingboche Exclusion Criteria: Unable to read the consent form Taken NSAIDs, acetazolamide, or corticosteroids in the week prior to study enrollment. Hazardous medical conditions which precludes the ability to tolerate the experimental device. Pregnancy or suspected pregnancy. Participants who are younger than 18 years of age and more than 65. Travel to or above 4200m in the preceding week. Diagnosis of AMS upon enrollment (LLS ≥3 with symptoms of headache) Previously diagnosed obstructive sleep apnea Current symptoms of nasal congestion, rhinorrhea, sinusitis, upper respiratory infection, asthma, COPD exacerbation, pneumonia, bronchitis, or other disease of the respiratory tract.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theravent<br>A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping. | Device: Theravent<br>* nasal EPAP device<br>|
| Sham Comparator: Control<br>A visibly identical sham device that does not provide positive end expiratory pressure. | Device: Control<br>* Sham device without EPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Acute Mountain Sickness | 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. | Approximately 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Nocturnal Desaturations | 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. | Approximately 10 hours | 
| Acute Mountain Sickness Severity | 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. | approximately 10 hours | 
| Nocturnal Awakenings | 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. | approximately 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positive end expiratory pressure, acute mountain sickness, prevention, high altitude