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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Mountain Sickness
• Intervention / Treatment: Device: Theravent; Device: Control

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
• Enrollment (Actual): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Khumbu
    • Pheriche & Dingboche, Khumbu, Nepal
      • Nepal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of Utah

Publications and helpful links

General Publications

• Lipman GS, Kanaan NC, Phillips C, Pomeranz D, Cain P, Fontes K, Higbee B, Meyer C, Shaheen M, Wentworth S, Walsh D. Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID). High Alt Med Biol. 2015 Jun;16(2):154-61. doi: 10.1089/ham.2014.1110. Epub 2015 May 7.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: prevention; positive end expiratory pressure; acute mountain sickness; high altitude
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: SLEEP-AID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No