Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)
Trial ID or NCT#
NCT01842906
Status
NOT RECRUITING
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 Criteria
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
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.
Contact us to find out if this trial is right for you.
Contact
Grant S Lipman, MD
415-290-9286
View on ClinicalTrials.gov
