Status:
COMPLETED
Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)
Lead Sponsor:
Stanford University
Collaborating Sponsors:
University of Utah
Conditions:
Acute Mountain Sickness
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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.
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 hik...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT01842906
Start Date
October 1 2013
End Date
October 1 2014
Last Update
December 13 2018
Active Locations (1)
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1
Nepal
Pheriche & Dingboche, Khumbu, Nepal