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Trial · NCT01519544

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryGlobal assessment of sleep quality using a 100mm visual analog scale1 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'.
PrimaryThe Groningen Sleep Quality Questionnaire survey1 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.
SecondarySleep Onset Latency1 dayThe amount of time it takes the subject to fall asleep. Reported by the subject.
SecondaryTotal Sleep Duration1 dayThe total amount of time that the subject slept. Recorded by the subject.
SecondaryTime in Bed1 dayThe amount of time the subject spent in bed. Recorded by the subject.
SecondaryNumber of Awakenings1 dayThe number of times the subject woke up from sleep. Recorded by the subject.
SecondaryNumber of Awakenings to Urinate1 dayNumber of time the subject woke up from sleep to use the restroom. Recorded by the subject.
SecondaryWake Time After Sleep Onset1 dayAmount of time the subject spent awake after falling asleep. Recorded by the subject.
SecondaryTerminal Wakefulness1 dayThe amount of time the subject spends in bed after waking up for the last time. Reported by the subject.
SecondaryGlobal assessment of sleep depth1 daySubjects will be asked to rate the depth of sleep on a 100mm visual analog scales.
SecondaryGlobal assessment of drowsiness1 daySubjects will be asked to assess their daytime drowsiness on a 100mm visual analog scale.
SecondaryStanford Sleepiness Scale scores1 dayDuring each of the eight hours after waking up, subjects will be asked to complete a Stanford Sleepiness Scale to measure how sleepy they are.
SecondaryLake Louis Acute Mountain Sickness delta score1 day
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.
SecondaryMean O2 Saturation1 dayStudy subjects will wear a pulse oximeter during the night that will record their oxygen saturation.
SecondaryProportion of time in periodic breathing1 day
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.
SecondaryNumber of desaturation events per hour1 day
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.
SecondaryNumber of awakenings per hour1 day
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.
SecondarySleep Efficiency1 day
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).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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