Enhancing Slow Wave Sleep With Sodium Oxybate

Sleep Clinical Trial

Official title:

Enhancing Slow Wave Sleep With Sodium Oxybate to Reduce the Behavioral and Physiological Impact of Sleep Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506974
• Other study ID #: 2007.002
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2007
• Last updated: September 25, 2008
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: September 2008
• Source: St. Luke's Hospital, Chesterfield, Missouri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
United States	Sleep Medicine and Research Center at St. Luke's Hospital	Chesterfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's Hospital, Chesterfield, Missouri	Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

Walsh JK, Hartman PG, Schweitzer PK. Slow-wave sleep deprivation and waking function. J Sleep Res. 1994 Mar;3(1):16-25. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MSLT		throughout the study
Primary	PVT		throughout the study