Clinical trial NCT00506974: Enhancing Slow Wave Sleep With Sodium Oxybate
Official title: Enhancing Slow Wave Sleep With Sodium Oxybate to Reduce the Behavioral and Physiological Impact of Sleep Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep
Keywords: sleep
normal sleepers
Lead sponsor: St. Luke's Hospital, Chesterfield, Missouri
Sponsor class: OTHER
Collaborators: name: Jazz Pharmaceuticals
First posted: 2007-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. males and females, ages 18-50 inclusive
2. use of adequate contraceptive procedures throughout the study for females.

Exclusion Criteria:

1. pregnancy or lactating
2. prior use of or allergy to sodium oxybate
3. participation in a clinical research trial within the past 30 days
4. blood donation within the past 30 days

Primary outcomes:
measure: MSLT
timeFrame: throughout the study
measure: PVT
timeFrame: throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Sleep Medicine and Research Center at St. Luke's Hospital
state: Missouri
Study officials:
affiliation: Sleep Medicine and Research Center at St. Luke's Hospital
name: James K Walsh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh JK, Hartman PG, Schweitzer PK. Slow-wave sleep deprivation and waking function. J Sleep Res. 1994 Mar;3(1):16-25. doi: 10.1111/j.1365-2869.1994.tb00099.x.
citation: Walsh JK, Randazzo AC, Stone K, Eisenstein R, Feren SD, Kajy S, Dickey P, Roehrs T, Roth T, Schweitzer PK. Tiagabine is associated with sustained attention during sleep restriction: evidence for the value of slow-wave sleep enhancement? Sleep. 2006 Apr;29(4):433-43.