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.
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | March 2015 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Nepal | Himalayan Rescue Location clinic in Manang | Manang | District of Manang |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital |
Nepal,
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* Note: There are 44 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Global assessment of sleep quality using a 100mm visual analog scale | The morning after taking the study medication, subjects will be asked: How would you rate last night's sleep quality? They will mark their answer on a 100mm visual analog scale with 0mm representing 'worst night of sleep ever' and 100mm representing 'best night of sleep ever'. | 1 day | No |
| Primary | The Groningen Sleep Quality Questionnaire survey | The Groningen Sleep Quality Questionnaire survey includes fifteen questions that describe sleep onset, sleep quality, awakenings, sleep duration, and wake up quality. Survey is completed by the subject. | 1 day | No |
| Secondary | Sleep Onset Latency | The amount of time it takes the subject to fall asleep. Reported by the subject. | 1 day | No |
| Secondary | Total Sleep Duration | The total amount of time that the subject slept. Recorded by the subject. | 1 day | No |
| Secondary | Time in Bed | The amount of time the subject spent in bed. Recorded by the subject. | 1 day | No |
| Secondary | Number of Awakenings | The number of times the subject woke up from sleep. Recorded by the subject. | 1 day | No |
| Secondary | Number of Awakenings to Urinate | Number of time the subject woke up from sleep to use the restroom. Recorded by the subject. | 1 day | No |
| Secondary | Wake Time After Sleep Onset | Amount of time the subject spent awake after falling asleep. Recorded by the subject. | 1 day | No |
| Secondary | Terminal Wakefulness | The amount of time the subject spends in bed after waking up for the last time. Reported by the subject. | 1 day | No |
| Secondary | Global assessment of sleep depth | Subjects will be asked to rate the depth of sleep on a 100mm visual analog scales. | 1 day | No |
| Secondary | Global assessment of drowsiness | Subjects will be asked to assess their daytime drowsiness on a 100mm visual analog scale. | 1 day | No |
| Secondary | Stanford Sleepiness Scale scores | During each of the eight hours after waking up, subjects will be asked to complete a Stanford Sleepiness Scale to measure how sleepy they are. | 1 day | No |
| Secondary | Lake Louis Acute Mountain Sickness delta score | Subjects will be asked to fill out a Lake Louise Acute Mountain Sickness score at the beginning and end of study participation. The Lake Louise Acute Mountain Sickness score reflects on the severity of Acute Mountain Sickness being experienced by the subject. Scores consistent moderate or severe Acute Mountain Sickness will exclude subjects from participation in the study. | 1 day | Yes |
| Secondary | Mean O2 Saturation | Study subjects will wear a pulse oximeter during the night that will record their oxygen saturation. | 1 day | Yes |
| Secondary | Proportion of time in periodic breathing | Visitors to high altitude experience periodic breathing (alternating periods of increased and decreased respiratory rate) as the human body adjusts to the hypoxemia of high altitude. Both temazepam and acetazolamide have been shown to improve periodic breathing. Subjects will wear pulse oximeters. Data from the pulse oximeters will be used to calculate the amount of time that subjects spend in periodic breathing. | 1 day | No |
| Secondary | Number of desaturation events per hour | Due to the periodic breathing that occurs at high altitude, there are frequent oxygen desaturations during sleep. Subjects will wear a pulse oximeter to determine how many time they experience a decline in their oxygen saturation during the night. | 1 day | Yes |
| Secondary | Number of awakenings per hour | Subjects will wear an actigraph while they sleep. Actigraphs are small wristwatch-like devices that measure subtle movements while a subject is asleep. These movements are used to objectively describe awake and asleep periods. | 1 day | No |
| Secondary | Sleep Efficiency | Subjects will wear an actigraph when they sleep. Actigraphs are small wristwatch-like devices that measure the subtle movements of a subject during the night and help objectively determine awake and asleep periods. Using data from the actigraph, one may calculate what percent of the night the subject was asleep (sleep efficiency). | 1 day | No |