Enhancing Slow Wave Sleep With Sodium Oxybate

This study has been completed.
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by:
St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier:
NCT00506974
First received: July 24, 2007
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Enhancing Slow Wave Sleep With Sodium Oxybate to Reduce the Behavioral and Physiological Impact of Sleep Loss

Resource links provided by NLM:


Further study details as provided by St. Luke's Hospital, Chesterfield, Missouri:

Primary Outcome Measures:
  • MSLT [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • PVT [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: sodium oxybate
    3.5 g of sodium oxybate or placebo on two of the five overnights.
    Other Name: xyrem
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506974

Locations
United States, Missouri
Sleep Medicine and Research Center at St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
Sponsors and Collaborators
St. Luke's Hospital, Chesterfield, Missouri
Jazz Pharmaceuticals
Investigators
Principal Investigator: James K Walsh, Ph.D. Sleep Medicine and Research Center at St. Luke's Hospital
  More Information

Publications:
Responsible Party: Dr. Paula Schweitzer, St. Luke's Hospital
ClinicalTrials.gov Identifier: NCT00506974     History of Changes
Other Study ID Numbers: 2007.002
Study First Received: July 24, 2007
Last Updated: September 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's Hospital, Chesterfield, Missouri:
sleep
normal sleepers

Additional relevant MeSH terms:
Sodium Oxybate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014