Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Acetazolamide; Temazepam

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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