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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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 Type

Interventional


Primary Outcome

Incidence of Acute Mountain Sickness

Secondary Outcome

 Number of Nocturnal Desaturations

Condition

Acute Mountain Sickness

Intervention

Theravent

Study Arms / Comparison Groups

 Theravent
Description:  A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

219

Start Date

October 2013

Completion Date

October 2014

Primary Completion Date

December 2013

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Grant S Lipman, MD, , 

Location Countries

Nepal

Location Countries

Nepal

Administrative Informations


NCT ID

NCT01842906

Organization ID

SLEEP-AID


Responsible Party

Principal Investigator

Study Sponsor

Stanford University

Collaborators

 University of Utah

Study Sponsor

Grant S Lipman, MD, Principal Investigator, Stanford University


Verification Date

November 2018