NCT00506974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

1.1 years

First QC Date

July 24, 2007

Last Update Submit

September 25, 2008

Conditions

Sleep

Keywords

sleepnormal sleepers

Outcome Measures

Primary Outcomes (2)

  • MSLT

    throughout the study

  • PVT

    throughout the study

Interventions

sodium oxybateDRUG

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

Also known as: xyrem

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • pregnancy or lactating
  • prior use of or allergy to sodium oxybate
  • participation in a clinical research trial within the past 30 days
  • blood donation within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chesterfield, Missouri, 63017, United States

Location

Related Publications (2)

  • 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.

    PMID: 10607104BACKGROUND

  • 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.

    PMID: 16676776BACKGROUND

MeSH Terms

Interventions

Sodium Oxybate

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Study Officials

  • James K Walsh, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 25, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

US(1)