SleepPhase 4NCT00506974
Enhancing Slow Wave Sleep With Sodium Oxybate
A Phase 4 study testing sodium oxybate in people with Sleep, run by St. Luke's Hospital, Chesterfield, Missouri at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- sodium oxybate
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males and females, ages 18-50 inclusive
- use of adequate contraceptive procedures throughout the study for females.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Medicine and Research Center at St. Luke's Hospital
Chesterfield, Missouri, 63017
About this study
Official title: Enhancing Slow Wave Sleep With Sodium Oxybate to Reduce the Behavioral and Physiological Impact of Sleep Loss
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.
Read the 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.
- Conditions
- Sleep
- Being tested
- sodium oxybate
- Keywords
- sleep, normal sleepers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium oxybateDrug
Also called xyrem
3.5 g of sodium oxybate or placebo on two of the five overnights.
What is being measured
The primary outcome is the main question the study is designed to answer.
MSLT
Measured: throughout the study
PVT
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Chesterfield, Missouri
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Investigators
- James K Walsh, Ph.D., Principal investigator, Sleep Medicine and Research Center at St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506974
- Sponsor's protocol ID
- 2007.002
- Status last verified
- Sep 2008
- First submitted
- 24 Jul 2007
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10607104Walsh 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.
PubMed 16676776
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Slow Wave Sleep With Sodium Oxybate to Reduce the Behavioral and Physiological Impact of Sleep Loss
- ClinicalTrials.gov ID
- NCT00506974
- Acronym / sponsor ID
- 2007.002
- Conditions
- Sleep
- Keywords
- sleep, normal sleepers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Luke's Hospital, Chesterfield, MissouriUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- May 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- males and females, ages 18-50 inclusive
- use of adequate contraceptive procedures throughout the study for females.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium oxybateAlso: xyrem3.5 g of sodium oxybate or placebo on two of the five overnights. | Drug | – |
Primary outcome
MSLT
Time frame: throughout the study
PVT
Time frame: throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
- Background: PubMed 10607104Walsh 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.
- Background: PubMed 16676776Walsh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James K Walsh, Ph.D. principal investigator
Sleep Medicine and Research Center at St. Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium oxybate in people with Sleep, run by St. Luke's Hospital, Chesterfield, Missouri at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSLT (time frame: throughout the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00506974, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2008.