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Sponsors and Collaborators: |
St. Luke's Hospital, Chesterfield, Missouri Jazz Pharmaceuticals |
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Information provided by: | St. Luke's Hospital, Chesterfield, Missouri |
ClinicalTrials.gov Identifier: | NCT00506974 |
The purpose of this study is to determine if there the impact of sleep deprivation upon sleepiness, attention, memory, and mood is reduced by pharmacologically enhancing slow wave sleep (SWS) with sodium oxybate.
Condition | Intervention | Phase |
---|---|---|
Sleep |
Drug: sodium oxybate |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | Enhancing Slow Wave Sleep With Sodium Oxybate to Reduce the Behavioral and Physiological Impact of Sleep Loss |
Enrollment: | 60 |
Study Start Date: | May 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
SWS has been hypothesized to be a time of relatively high neural recuperation from wakefulness. That hypothesis has been prompted by a number of observations, including: 1) enhanced SWS following sleep deprivation in proportion to the duration of prior wakefulness, 2) reduced amounts of SWS during nocturnal sleep following afternoon/evening naps, 3) a gradual decline in SWS across a night of sleep, and 4) increased SWS following nights of fragmented sleep. Within the two-process model of sleep regulation, heightened SWS has been viewed as reflecting Process S, the homeostatic component. Many authors have proposed that increased SWS represents ongoing cortical recovery from prior wakefulness activities and is a time of relatively heightened neurophysiologic restoration or recuperation. In a prior study which we conducted (Walsh et al., 1994) there was a suggestion, from post hoc analyses, that SWS may prevent adverse effects of sleep loss. Additionally, we recently published the results of an investigation of pharmacologically-enhanced SWS (with tiagabine) during sleep restriction which demonstrated preserved neurobehavioral performance despite sleep restriction (Walsh et al, 2006). In the proposed research we will examine whether pharmacological enhancement of SWS with sodium oxybate reduces the impact of sleep deprivation upon sleepiness, attention, performance, mood, and autonomic nervous system activity.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Sleep Medicine and Research Center at St. Luke's Hospital | |
Chesterfield, Missouri, United States, 63017 |
Principal Investigator: | James K Walsh, Ph.D. | Sleep Medicine and Research Center at St. Luke's Hospital |
Responsible Party: | St. Luke's Hospital ( Dr. Paula Schweitzer ) |
Study ID Numbers: | 2007.002 |
Study First Received: | July 24, 2007 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00506974 |
Health Authority: | United States: Institutional Review Board |
sleep normal sleepers |
Sodium Oxybate |
Anesthetics, Intravenous Adjuvants, Anesthesia Anesthetics, General Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Depressants Anesthetics Central Nervous System Agents Pharmacologic Actions |