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Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)
Not Recruiting
Trial ID: NCT01842906
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.
Official Title
Randomized Controlled Trial for Assessment of a Novel Non-Pharmacologic Intervention for Decrease in Altitude Illness
Eligibility
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.
Intervention(s):
device: Theravent
device: Control
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Grant S Lipman, MD
415-290-9286