Status:
COMPLETED
Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude
Lead Sponsor:
Massachusetts General Hospital
Conditions:
High-altitude Sleep Disturbance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 acetazolam...
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. Diffi...
Eligibility Criteria
Inclusion
- Trekkers on the Annapurna circuit
- Must be in the process of ascent (\> 200 meters over the previous 24 hours)
- Must be willing to stay 2 nights in Manang, Nepal
- Healthy adults, age 18-65
- Self-report of new difficulty sleeping over the previous two days
Exclusion
- Recent (\< 2 weeks) high altitude exposure (higher than 11, 500 feet or 3500 meters)
- Current acute illness
- Moderate to Severe Acute Mountain Sickness (Lake Louise AMS score \> 4)
- High Altitude Cerebral Edema
- High Altitude Pulmonary Edema
- Any pre-existing sleep disorders or sleep related condition including obstructive sleep apnea, morbid obesity (BMI \> 40), restless leg syndrome, etc.
- Any lung disease or condition affecting the lungs, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc.
- Congestive heart failure, pulmonary hypertension, or cardiomyopathy
- Current oxygen use
- Kidney disease
- Liver disease
- Pregnancy or breast feeding
- Seizure disorder or other neurologic disorder
- Glaucoma
- Sulfa allergy
- Acetazolamide allergy
- Benzodiazepine allergy
- Temazepam allergy
- Currently on acetazolamide
- Currently taking any benzodiazepines
- Current medical treatment with any of the following: antidepressants, neuroleptics, anxiolytics, H1 antihistamines, barbiturates or hypnotics (including benzodiazepines or any other sleep aids).
- Major psychiatric diagnosis (depression, anxiety, schizophrenia)
- Recreational drug use
- Caffeine con¬sumption \> 3 cups of coffee/day
- Alcohol consumption \> 1 drink/day
- Mental Retardation or Developmental Disabilities
- Inability to provide informed consent
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01519544
Start Date
March 1 2012
End Date
March 1 2015
Last Update
April 23 2015
Active Locations (1)
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1
Himalayan Rescue Location clinic in Manang
Manang, District of Manang, Nepal, 33500