Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude
Condition: High-altitude Sleep Disturbance
MeSH terms: Altitude Sickness; Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Temazepam; Acetazolamide
Intervention type(s): Drug; Drug
Intervention description(s): Temazepam 7.5mg capsule to be taken by mouth at bedtime for one night only.; Take Acetazolamide 125mg tablet by mouth at bedtime for one night only.
Other intervention name(s): Restoril; Diamox
Intervention MeSH terms: Acetazolamide; Temazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sleep; High Altitude; High-altitude Sleep Disturbance; Acute Mountain Sickness; Difficulty Sleeping at High Altitude; Periodic Breathing; Actigraphy; Acetazolamide; Temazepam; Groningen Sleep Quality Questionnaire survey; Stanford Sleepiness Scale; Lake Louise Acute Mountain Sickness Score