The Effect of Sodium Oxybate on Sleep Architecture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744393
Recruitment Status : Withdrawn (Sponsor pulled funding secondary to economy issues)
First Posted : September 1, 2008
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
The purpose of this study is to determine what effect sodium oxybate has on the functions of sleep in mechanically ventilated, critically ill patients hospitalized in an intensive care unit.

Condition or disease Intervention/treatment Phase
Mechanically Ventilated ICU Patients Drug: sodium oxybate Drug: placebo Phase 2

Detailed Description:

Sleep is disrupted in the critically ill and may lead to impaired neurocognitive function, decreased immune function, increased protein catabolism, and may compromise the ability to wean patients from mechanical ventilation. Critically ill patients may appear to sleep throughout most of their stay, but their quality of sleep is different from that of a normal healthy subject.Critically ill patients spend more time in the wakefulness stages of sleep (Stage 1 and 2) at the expense of the restorative stages (Stage 3 and 4) and REM sleep. These patients also experience an increased number of arousals and awakenings. Various factors are thought to be the cause of abnormal sleep architecture: ICU environment, pain, illness severity, psychosocial stress, medications, and mechanical ventilation.

Sodium oxybate (Xyrem®) is the sodium salt of the central nervous system depressant γ-hydroxybutyric acid (GHB) and is currently approved for use in narcoleptic patients to improve cataplexy and excessive daytime sleepiness.

Studies evaluating the use of sodium oxybate in narcoleptic patients suggest that sodium oxybate is effective at increasing slow-wave sleep, sleep efficiency, sleep latency, and REM-sleep efficiency, while also decreasing REM-sleep latency, stage 1 NREM sleep and sleep fragmentation.3, 16-19 Currently there is a lack of data evaluating the effects of sodium oxybate on sleep in critically ill patients. Obtaining evidence that sodium oxybate improves sleep architecture in the critically ill, may provide the foundation to complete future studies evaluating the effect of sodium oxybate on clinical outcomes such as duration of mechanical ventilation and length of ICU stay. Based on sodium oxybate's ability to improve sleep architecture in narcoleptic patients along with the fact that critically ill patients have similar disrupted sleep architecture, it's postulated that sodium oxybate may improve the sleep architecture in critically ill patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sodium Oxybate on Sleep Architecture in Critically Ill Patients: A Double-Blind, Crossover Pilot Study
Study Start Date : October 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Active drug
Drug: sodium oxybate
The dose of sodium oxybate will be 4.5g every 4 hours x 2 doses. The first dose of study medication will be given at 10pm followed by the next dose four hours later and crossed over the next day
Other Name: XYREM
Placebo Comparator: P
Placebo drug
Drug: placebo
The dose of placebo sodium oxybate will be 4.5g every 4 hours x 2 doses. The first dose of study medication will be given at 10pm followed by the next dose four hours later and then crossed over the next day
Other Name: Xyrem

Primary Outcome Measures :
  1. To gain a better understanding of the effect of sodium oxybate on the following components of sleep architecture: % time in sleep stage and arousals and awakenings [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. To observe any short-term adverse effects of sodium oxybate in mechanically ventilated ICU patients [ Time Frame: 72 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years
  • Mechanically ventilated ≥ 24º on an AC mode
  • Placement of enteral or gastric tube (Note: these tubes will not be placed exclusively for the purposes of the study.)
  • Tolerating enteral nutrition via either the stomach or small intestine (≥20mL/hr for ≥ 12 hours)

Exclusion Criteria:

  • Anticipated duration of mechanical ventilation ≤72º (as per MICU team estimate)
  • Riker SAS ≤ 2 (as determined by patient's nurse and/or study investigator)
  • History of irreversible brain disease consistent with severe dementia based on MICU service admission note
  • Admitted with a primary neurological condition (e.g. intracranial hemorrhage)
  • History of seizure disorder or intracranial surgery
  • History of myocardial infarction in prior 6 months
  • Pregnancy (all women of child bearing potential will undergo a serum pregnancy test prior to study consent)
  • Administration of a scheduled benzodiazepine as either a continuous drip or given by IVP
  • Acute alcohol withdrawal
  • AST/ALT >2 times ULN, INR >2 or T bilirubin > 1.5
  • Current or prior use of sodium oxybate in the -past 30 days.
  • Hypernatremia with a serum sodium >150
  • Current use of the following hypnotics: barbiturates, melatonin, zolpidem, eszopiclone, or zaleplon
  • Use of neuromuscular blocking agents
  • Allergy to sodium oxybate
  • Known succinic semialdehyde dehydrogenase deficiency
  • History of periodic limb movement disorder.
  • A prognosis considered to be hopeless (as per MICU team)
  • Inability to obtain informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744393

United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Principal Investigator: Carolyn D'Ambrosio, MD Tufts Medical Center

Responsible Party: Tufts Medical Center Identifier: NCT00744393     History of Changes
Other Study ID Numbers: NEMC-8479
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by Tufts Medical Center:
critically ill
mechanical ventilation

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