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Acute Mountain Sickness | Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)

Acute Mountain Sickness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Mountain Sickness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Theraventnasal EPAP device

Device:ControlSham device without EPAP

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

TheraventA singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.

ControlA visibly identical sham device that does not provide positive end expiratory pressure.

Study Status

Completed

Start Date: October 2013

Completed Date: October 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Incidence of Acute Mountain Sickness

Secondary Outcome: Number of Nocturnal Desaturations

Study sponsors, principal investigator, and references

Principal Investigator: Grant S Lipman, MD

Lead Sponsor: Stanford University

Collaborator: University of Utah

More information:https://clinicaltrials.gov/show/NCT01842906

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