N/A
N=219
Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)
Acute Mountain Sickness
Bottom Line
View on ClinicalTrials.gov: NCT01842906 ↗Enrolled (actual)
219
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Incidence of Acute Mountain Sickness — 18; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Theravent (Device); Control (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Acute Mountain Sickness |
18; 16 | — |
| SECONDARY Number of Nocturnal Desaturations |
270; 214 | — |
| SECONDARY Acute Mountain Sickness Severity |
0.46; 0.26; 0.15; 0.20; 0.15; 0.049 | — |
| SECONDARY Nocturnal Awakenings |
11; 13 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01842906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.