High-altitude Sleep Disturbance Clinical Trial
Official title:
Treatment of High-altitude Sleep Disturbance: A Double-blind Comparison of Temazepam Versus Acetazolamide.
More than 70% of visitors to high altitude suffer poor sleep. The present study seeks to answer the question: Which medication is associated with better sleep at high altitude: temazepam or acetazolamide? The investigators hypothesis is that one medication will be associated with higher subjective sleep scores than the other. The study will compare the sleep quality of 100 subjects as they take either temazepam or acetazolamide during a visit to high altitude.
Difficulty sleeping is very common with acute high altitude exposure. Sleep disturbances
were reported by more than 70% of participants in acute mountain sickness pharmacologic
treatment trials. Difficulty sleeping is one of the primary complaints of visitors to high
altitude and some authors consider difficulty sleeping to be nearly universal at high
altitudes. Acetazolamide, temazepam, zolpidem and zaleplon are all effective and safe in
treating the acute insomnia of high altitude. No head-to-head trials have been performed to
determine the best drug class for treatment of high altitude sleep disturbances. The purpose
of this study is to compare temazepam and acetazolamide in the treatment of high altitude
sleep disturbances. Such knowledge will benefit the hundreds of thousands of visitors to
areas of high altitude throughout the world.
The study will be a convenience sample of 100 trekkers in Manang, Nepal (elevation 11,500
feet). The study will only enroll trekkers who have gained more than 200 meters (650 feet)
over the preceding 24 hours. Subject enrollment will take place from March 1, 2012, through
May 30, 2012. One hundred subjects will be enrolled.
All subjects will complete the study in Manang, Nepal. Once an individual decides to enroll
in the study, they will be instructed on the risks of the study and informed consent will be
obtained. Eligibility to participate will be verified.
Each subject will be randomly assigned to take 125 mg of acetazolamide or 7.5 mg of
temazepam by mouth immediately prior to going to bed. Each subject will only take one dose
of the medication as part of the trial. Subjects will wear a pulse oximeter and an actigraph
to bed. An actigraph is an accelerometer that is worn like a wrist watch. Actigraphs can
sense and record movement and for this reason are often used in sleep studies to help
measure sleep duration and quality.
Study participants will keep a sleep log and will be asked to complete a Groningen Sleep
Quality Questionnaire Survey and Lake Louise Acute Mountain Sickness questionnaire. Subjects
will also complete a Stanford Sleepiness Scale every hour for eight hours.
Through both objective and subjective measurement of sleep quality, this study is designed
to determine which medication is associated with improved sleep at high altitude.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment