High-altitude Sleep DisturbanceNCT01519544
Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude
A study testing Temazepam and Acetazolamide in people with High-altitude Sleep Disturbance, run by Massachusetts General Hospital at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High-altitude Sleep Disturbance
- What is being tested?
- Temazepam and Acetazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNepal
- Study dates
- Mar 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Himalayan Rescue Location clinic in Manang
Manang, District of Manang, 33500
About this study
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.
Read the 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.
- Conditions
- High-altitude Sleep Disturbance
- Being tested
- Temazepam, Acetazolamide
- 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
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemazepamDrug
Also called Restoril
Temazepam 7.5mg capsule to be taken by mouth at bedtime for one night only.
AcetazolamideDrug
Also called Diamox
Take Acetazolamide 125mg tablet by mouth at bedtime for one night only.
| Study group | Role | What they receive |
|---|---|---|
| Temazepam | Active comparator | 50 subjects are instructed to take 7.5mg temazepam by mouth prior to going to sleep for one night only. Receives: Drug: Temazepam |
| Acetazolamide | Active comparator | 50 subjects are instructed to take 125mg of acetazolamide by mouth prior to going to sleep one night only. Receives: Drug: Acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (16)
Sleep Onset Latency
The amount of time it takes the subject to fall asleep. Reported by the subject.
Measured: 1 day
Total Sleep Duration
The total amount of time that the subject slept. Recorded by the subject.
Measured: 1 day
Time in Bed
The amount of time the subject spent in bed. Recorded by the subject.
Measured: 1 day
Number of Awakenings
The number of times the subject woke up from sleep. Recorded by the subject.
Measured: 1 day
Number of Awakenings to Urinate
Number of time the subject woke up from sleep to use the restroom. Recorded by the subject.
Measured: 1 day
Wake Time After Sleep Onset
Amount of time the subject spent awake after falling asleep. Recorded by the subject.
Measured: 1 day
Terminal Wakefulness
The amount of time the subject spends in bed after waking up for the last time. Reported by the subject.
Measured: 1 day
Global assessment of sleep depth
Subjects will be asked to rate the depth of sleep on a 100mm visual analog scales.
Measured: 1 day
Global assessment of drowsiness
Subjects will be asked to assess their daytime drowsiness on a 100mm visual analog scale.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Mean O2 Saturation
Study subjects will wear a pulse oximeter during the night that will record their oxygen saturation.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for High-altitude Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N. Stuart Harris MD MFA, Massachusetts General Hospital
- Investigators
- Norman S Harris, MD, MFA, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519544
- Sponsor's protocol ID
- 2012P000017
- Status last verified
- Apr 2015
- First submitted
- 24 Jan 2012
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Larson EB, Roach RC, Schoene RB, Hornbein TF. Acute mountain sickness and acetazolamide. Clinical efficacy and effect on ventilation. JAMA. 1982 Jul 16;248(3):328-32.
PubMed 7045433Ellsworth AJ, Larson EB, Strickland D. A randomized trial of dexamethasone and acetazolamide for acute mountain sickness prophylaxis. Am J Med. 1987 Dec;83(6):1024-30. doi: 10.1016/0002-9343(87)90937-5.
PubMed 3332564Honigman B, Theis MK, Koziol-McLain J, Roach R, Yip R, Houston C, Moore LG, Pearce P. Acute mountain sickness in a general tourist population at moderate altitudes. Ann Intern Med. 1993 Apr 15;118(8):587-92. doi: 10.7326/0003-4819-118-8-199304150-00003.
PubMed 8452324Forwand SA, Landowne M, Follansbee JN, Hansen JE. Effect of acetazolamide on acute mountain sickness. N Engl J Med. 1968 Oct 17;279(16):839-45. doi: 10.1056/NEJM196810172791601. No abstract available.
PubMed 4877992Dubowitz G. Effect of temazepam on oxygen saturation and sleep quality at high altitude: randomised placebo controlled crossover trial. BMJ. 1998 Feb 21;316(7131):587-9. doi: 10.1136/bmj.316.7131.587.
PubMed 9518909Nickol AH, Leverment J, Richards P, Seal P, Harris GA, Cleland J, Dubowitz G, Collier DJ, Milledge J, Stradling JR, Morrell MJ. Temazepam at high altitude reduces periodic breathing without impairing next-day performance: a randomized cross-over double-blind study. J Sleep Res. 2006 Dec;15(4):445-54. doi: 10.1111/j.1365-2869.2006.00558.x.
PubMed 17118102Beaumont M, Batejat D, Coste O, Van Beers P, Colas A, Clere JM, Pierard C. Effects of zolpidem and zaleplon on sleep, respiratory patterns and performance at a simulated altitude of 4,000 m. Neuropsychobiology. 2004;49(3):154-62. doi: 10.1159/000076723.
PubMed 15034230Beaumont M, Batejat D, Pierard C, Van Beers P, Philippe M, Leger D, Savourey G, Jouanin JC. Zaleplon and zolpidem objectively alleviate sleep disturbances in mountaineers at a 3,613 meter altitude. Sleep. 2007 Nov;30(11):1527-33. doi: 10.1093/sleep/30.11.1527.
PubMed 18041485Sharma A, Dewan VK. A Case Report of Zolpidem-Induced Somnambulism. Prim Care Companion J Clin Psychiatry. 2005;7(2):74. doi: 10.4088/pcc.v07n0207a. No abstract available.
PubMed 15841201Yang W, Dollear M, Muthukrishnan SR. One rare side effect of zolpidem--sleepwalking: a case report. Arch Phys Med Rehabil. 2005 Jun;86(6):1265-6. doi: 10.1016/j.apmr.2004.11.022.
PubMed 15954071Auerbach, Paul S. Wilderness Medicine, 5th ed. Mosby, Phidelphia. Pages 4-8. 2007.
Luks AM. Which medications are safe and effective for improving sleep at high altitude? High Alt Med Biol. 2008 Fall;9(3):195-8. doi: 10.1089/ham.2008.1025.
PubMed 18800955Sutton JR, Gray GW, Houston CS, Powles AC. Effects of duration at altitude and acetazolamide on ventilation and oxygenation during sleep. Sleep. 1980;3(3-4):455-64. doi: 10.1093/sleep/3.3-4.455. No abstract available.
PubMed 7221351Sutton JR, Houston CS, Mansell AL, McFadden MD, Hackett PM, Rigg JR, Powles AC. Effect of acetazolamide on hypoxemia during sleep at high altitude. N Engl J Med. 1979 Dec 13;301(24):1329-31. doi: 10.1056/NEJM197912133012406. No abstract available.
PubMed 503151Hackett PH, Roach RC, Harrison GL, Schoene RB, Mills WJ Jr. Respiratory stimulants and sleep periodic breathing at high altitude. Almitrine versus acetazolamide. Am Rev Respir Dis. 1987 Apr;135(4):896-8. doi: 10.1164/arrd.1987.135.4.896.
PubMed 3565935
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of High-altitude Sleep Disturbance: A Double-blind Comparison of Temazepam Versus Acetazolamide.
- ClinicalTrials.gov ID
- NCT01519544
- Acronym / sponsor ID
- 2012P000017
- Conditions
- High-altitude Sleep Disturbance
- Keywords
- Sleep, High Altitude, High-altitude Sleep Disturbance, Acute Mountain Sickness, Difficulty Sleeping at High Altitude, Periodic Breathing, Actigraphy, Acetazolamide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temazepam | Active comparator | Drug: Temazepam50 subjects are instructed to take 7.5mg temazepam by mouth prior to going to sleep for one night only. |
| Acetazolamide | Active comparator | Drug: Acetazolamide50 subjects are instructed to take 125mg of acetazolamide by mouth prior to going to sleep one night only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemazepamAlso: RestorilTemazepam 7.5mg capsule to be taken by mouth at bedtime for one night only. | Drug | Temazepam |
| AcetazolamideAlso: DiamoxTake Acetazolamide 125mg tablet by mouth at bedtime for one night only. | Drug | Acetazolamide |
Primary outcome
Global assessment of sleep quality using a 100mm visual analog scale
Time frame: 1 day
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'.
The Groningen Sleep Quality Questionnaire survey
Time frame: 1 day
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.
16 secondary outcomes
Sleep Onset Latency
Time frame: 1 day
Total Sleep Duration
Time frame: 1 day
Time in Bed
Time frame: 1 day
Number of Awakenings
Time frame: 1 day
Number of Awakenings to Urinate
Time frame: 1 day
Wake Time After Sleep Onset
Time frame: 1 day
Terminal Wakefulness
Time frame: 1 day
Global assessment of sleep depth
Time frame: 1 day
Global assessment of drowsiness
Time frame: 1 day
Stanford Sleepiness Scale scores
Time frame: 1 day
Lake Louis Acute Mountain Sickness delta score
Time frame: 1 day
Mean O2 Saturation
Time frame: 1 day
Proportion of time in periodic breathing
Time frame: 1 day
Number of desaturation events per hour
Time frame: 1 day
Number of awakenings per hour
Time frame: 1 day
Sleep Efficiency
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Background: PubMed 7045433Larson EB, Roach RC, Schoene RB, Hornbein TF. Acute mountain sickness and acetazolamide. Clinical efficacy and effect on ventilation. JAMA. 1982 Jul 16;248(3):328-32.
- Background: PubMed 3332564Ellsworth AJ, Larson EB, Strickland D. A randomized trial of dexamethasone and acetazolamide for acute mountain sickness prophylaxis. Am J Med. 1987 Dec;83(6):1024-30. doi: 10.1016/0002-9343(87)90937-5.
- Background: PubMed 8452324Honigman B, Theis MK, Koziol-McLain J, Roach R, Yip R, Houston C, Moore LG, Pearce P. Acute mountain sickness in a general tourist population at moderate altitudes. Ann Intern Med. 1993 Apr 15;118(8):587-92. doi: 10.7326/0003-4819-118-8-199304150-00003.
- Background: PubMed 4877992Forwand SA, Landowne M, Follansbee JN, Hansen JE. Effect of acetazolamide on acute mountain sickness. N Engl J Med. 1968 Oct 17;279(16):839-45. doi: 10.1056/NEJM196810172791601. No abstract available.
- Background: PubMed 9518909Dubowitz G. Effect of temazepam on oxygen saturation and sleep quality at high altitude: randomised placebo controlled crossover trial. BMJ. 1998 Feb 21;316(7131):587-9. doi: 10.1136/bmj.316.7131.587.
- Background: PubMed 17118102Nickol AH, Leverment J, Richards P, Seal P, Harris GA, Cleland J, Dubowitz G, Collier DJ, Milledge J, Stradling JR, Morrell MJ. Temazepam at high altitude reduces periodic breathing without impairing next-day performance: a randomized cross-over double-blind study. J Sleep Res. 2006 Dec;15(4):445-54. doi: 10.1111/j.1365-2869.2006.00558.x.
- Background: PubMed 15034230Beaumont M, Batejat D, Coste O, Van Beers P, Colas A, Clere JM, Pierard C. Effects of zolpidem and zaleplon on sleep, respiratory patterns and performance at a simulated altitude of 4,000 m. Neuropsychobiology. 2004;49(3):154-62. doi: 10.1159/000076723.
- Background: PubMed 18041485Beaumont M, Batejat D, Pierard C, Van Beers P, Philippe M, Leger D, Savourey G, Jouanin JC. Zaleplon and zolpidem objectively alleviate sleep disturbances in mountaineers at a 3,613 meter altitude. Sleep. 2007 Nov;30(11):1527-33. doi: 10.1093/sleep/30.11.1527.
- Background: PubMed 15841201Sharma A, Dewan VK. A Case Report of Zolpidem-Induced Somnambulism. Prim Care Companion J Clin Psychiatry. 2005;7(2):74. doi: 10.4088/pcc.v07n0207a. No abstract available.
- Background: PubMed 15954071Yang W, Dollear M, Muthukrishnan SR. One rare side effect of zolpidem--sleepwalking: a case report. Arch Phys Med Rehabil. 2005 Jun;86(6):1265-6. doi: 10.1016/j.apmr.2004.11.022.
- BackgroundAuerbach, Paul S. Wilderness Medicine, 5th ed. Mosby, Phidelphia. Pages 4-8. 2007.
- Background: PubMed 18800955Luks AM. Which medications are safe and effective for improving sleep at high altitude? High Alt Med Biol. 2008 Fall;9(3):195-8. doi: 10.1089/ham.2008.1025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman S Harris, MD, MFA principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temazepam and Acetazolamide in people with High-altitude Sleep Disturbance, run by Massachusetts General Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global assessment of sleep quality using a 100mm visual analog scale (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01519544, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.