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

This study has been completed.
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01842906
First received: April 22, 2013
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Acute Mountain Sickness
Device: Theravent
Device: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial for Assessment of a Novel Non-Pharmacologic Intervention for Decrease in Altitude Illness

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Incidence of acute mountain sickness [ Time Frame: Approximately 10 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • number of nocturnal desaturations [ Time Frame: Approximately 10 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Severity of acute mountain sickness will be evaluated by the Lake Louise Criteria. 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 ] [ Designated as safety issue: No ]
    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.

  • subjective quality of sleep [ Time Frame: approximately 10 hours ] [ Designated as safety issue: No ]
    Quality of sleep will be analyzed by sub-group analysis of the Lake Louise Criteria( 0 to 3 scale) for acute mountain sickness. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.


Enrollment: 219
Study Start Date: October 2013
Study Completion Date: October 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Theravent
A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
Device: Theravent
nasal EPAP device
Sham Comparator: Control
A visibly identical sham device that does not provide positive end expiratory pressure.
Device: Control
Sham device without EPAP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842906

Locations
Nepal
Nepal
Pheriche & Dingboche, Khumbu, Nepal
Sponsors and Collaborators
Stanford University
University of Utah
Investigators
Principal Investigator: Grant S Lipman, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01842906     History of Changes
Other Study ID Numbers: SLEEP-AID
Study First Received: April 22, 2013
Last Updated: October 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
positive end expiratory pressure
acute mountain sickness
prevention
high altitude

Additional relevant MeSH terms:
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014