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Enhancing Slow Wave Sleep With Sodium Oxybate

NCT ID: NCT00506974

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Sleep

Keywords

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sleep normal sleepers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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sodium oxybate

3.5 g of sodium oxybate or placebo on two of the five overnights.

Intervention Type DRUG

Other Intervention Names

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xyrem

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

St. Luke's Hospital, Chesterfield, Missouri

OTHER

Sponsor Role lead

Responsible Party

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St. Luke's Hospital

Principal Investigators

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James K Walsh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sleep Medicine and Research Center at St. Luke's Hospital

Locations

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Sleep Medicine and Research Center at St. Luke's Hospital

Chesterfield, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10607104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16676776 (View on PubMed)

Other Identifiers

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2007.002

Identifier Type: -

Identifier Source: org_study_id