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A study to evaluate the effect of sodium oxybate on sleep quality in adult patients in intensive care units

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on adults receiving care in the intensive care unit, which is a specialized hospital department for patients with serious illnesses. Many patients in this setting experience sleep disorders, which are problems with the quality or amount of sleep. The research aims to determine if the administration of sodium oxybate (also known as GAMMA-OH) through an intravenous line, which is a needle placed into a vein, can increase the amount of deep slow-wave sleep. This specific stage of sleep is the deepest part of the sleep cycle, essential for rest and recovery.

During the study, participants may receive either GAMMA-OH or a placebo, which is a substance containing NaCl 0.9% (salt water) with no active medicine. The study uses polysomnography, a method of monitoring sleep through various sensors, to observe different sleep stages such as Rapid Eye Movement (REM) sleep and light sleep. Researchers will also look at how the treatment affects daytime alertness and the need for pain medications like morphine. Additionally, the study monitors for potential side effects, such as bradycardia, which is a slow heart rate, or changes in blood sodium levels.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    An intravenous injection, which is a medication delivered directly into a vein, is performed.

    One group receives sodium oxybate at a dose of 9.5 grams to study its effect on deep sleep.

    Another group receives a placebo, which is a saline solution (NaCl 0.9%) that contains no active medicine, to serve as a comparison.

  2. Step 2

    <b>sleep monitoring</b>

    Sleep is monitored using polysomnography, which involves recording brain activity and other bodily functions to measure sleep stages.

    The duration of deep slow-wave sleep, also known as the n3 stage, is measured in minutes.

    Various aspects of sleep are recorded, including how long it takes to fall asleep, the total amount of sleep, the amount of light sleep, rapid eye movement (rem) sleep, and any periods of waking up during the night.

  3. Step 3

    <b>follow-up assessments</b>

    daytime alertness is evaluated the morning after the study night using a scale to measure sleepiness and a maintenance of wakefulness test.

    The amount of pain medication used is tracked.

    The level of participation in rehabilitation, which is physical or occupational therapy, is assessed.

    safety monitoring is conducted to check for side effects, such as low potassium levels, high sodium levels, confusion, agitation, high blood pressure, or a slow heart rate.

Who can join the trial?

4 criteria

  • You must be an adult, which means you are 18 years of age or older.
  • You must be staying in the ICU, which is the Intensive Care Unit, a special hospital area for patients who need very close monitoring and constant care.
  • You must have been in the ICU for more than 48 hours.
  • You must provide informed consent, which means you agree to take part in the study after being given all the necessary information about it.

Who cannot join the trial?

23 criteria

  • Patients who are unstable, meaning their physical condition is changing quickly or is not steady.
  • Patients who have had a recent head trauma (injury to the head) or a neurological injury (damage to the brain or nervous system).
  • Patients with severe hypertension, which is very high blood pressure that stays above 180/120 even while taking blood pressure medicine.
  • Patients with hypokalemia, which means having a low level of potassium (a mineral in the blood) that does not improve with supplements.
  • Patients who have or might have succinic semialdehyde dehydrogenase (SSADH) deficiency, a condition where the body cannot properly break down certain substances, which could cause the study medicine to build up to dangerous levels.
  • Patients who are not using a breathing machine but are taking opioids (strong pain medicines) or barbiturates (medicines used to treat seizures or help with sleep).
  • Patients with hypernatraemia, which is too much sodium (salt) in the blood, or hyperchloraemia, which is too much chloride (a mineral) in the blood.
  • Patients with hepatic impairment, which means the liver is not working properly (specifically classified as stage B or C).
  • Patients with a cardiac conduction disorder, which is a problem with the electrical signals that tell the heart how to beat.
  • Patients with obstructive sleep apnea syndrome, a condition where breathing repeatedly stops and starts during sleep.
  • Patients on a sodium restriction, meaning they eat less than 3 grams of salt in a 24-hour period.
  • Patients who do not have social security or are on state medical aid.
  • Patients in a state of deep sedation, which is a very heavy sleep-like state where they are difficult to wake up, measured by a specific scale called the RASS score.
  • Patients experiencing mental confusion, which is checked using a tool called the CAM-ICU.
  • Patients who are moribund, meaning they are very close to death, or those who are likely to pass away within 48 hours.
  • Patients under legal protection, such as having a guardianship or curatorship (someone else is legally making decisions for them).
  • Patients who are already participating in another interventional clinical trial involving sleep, confusion, or sedation management.
  • Patients with a known allergy to the study medicine, Gamma-Hydroxybutyrate, or any of its excipients (the inactive ingredients used to make the medicine).
  • Patients for whom it is technically impossible to perform a polysomnography (a sleep study that records brain waves and breathing).
  • Women who are pregnant or breastfeeding.
  • Patients who are already enrolled in this specific study.
  • Patients with a history of chronic alcoholism.
  • Patients with uncontrolled epilepsy, which is a condition causing seizures that are not being managed by medicine.
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Investigated drugs

Sodium oxybate is a medication given through an intravenous line (a tube in the vein) to help increase the amount of time a critically ill patient spends in deep, restorative sleep.

What is already known about the treatment

  • NaCl 0.9%

    This is a sterile salt solution administered through a vein to act as a placebo in this study. It is a widely used substance in medical practice to maintain fluid balance and deliver other medications. It works by matching the salt concentration in the body, meaning it has no direct effect on brain activity or sleep patterns.

  • Sodium oxybate

    This medication is given as a liquid through an intravenous injection to help improve deep sleep stages. It is currently studied for its ability to influence brain activity and is classified as a central nervous system depressant. At a molecular level, it works by interacting with specific receptors in the brain that help regulate sleep and relaxation.

Investigated diseases

Sleep disorders - These are disturbances that affect the quality, timing, or amount of sleep an individual experiences. In a critical care setting, these conditions often manifest as fragmented rest or changes in the natural sleep cycle. The progression involves interruptions in the normal stages of sleep, such as deep slow-wave sleep or rapid eye movement sleep. This can lead to increased wakefulness during the night and decreased alertness during the day. The disorder affects the body's ability to maintain consistent and restorative rest patterns.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521967-11-00Protocol codeAPHP241595Estimated enrolment24 patientsSponsorAssistance Publique Hopitaux De Paris

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