SODIUM OXYBATE for Sleep disturbance

Inclusion criteria

• {"criterion_text":"- Aged 18 years or older"}
• {"criterion_text":"- Hospitalized in the ICU for more than 48 hours"}
• {"criterion_text":"- Informed consent obtained from the patient"}

Exclusion criteria

• {"criterion_text":"- Unstable patient"}
• {"criterion_text":"- Lack of social security or on AME (state medical aid)"}
• {"criterion_text":"- Participation in another interventional clinical trial related to the management of sleep disorders, delirium, or sedation in the ICU."}
• {"criterion_text":"- Known allergy to Gamma-Hydroxybutyrate or any of the exipients"}
• {"criterion_text":"- Technical impossibility of performing polysomnography"}
• {"criterion_text":"- Positive pregnancy test for women of childbearing age or breastfeeding"}
• {"criterion_text":"- Patient already included in this study"}
• {"criterion_text":"- History of chronic alcoholism"}
• {"criterion_text":"- Uncontrolled epilepsy despite appropriate antiepileptic treatment"}
• {"criterion_text":"- Recent head trauma or neurological injury"}
• {"criterion_text":"- Severe hypertension: SBP > 180 mmHg despite antihypertensive treatment"}
• {"criterion_text":"- Hypokalemia < 3.5 mmol/L despite potassium supplementation"}
• {"criterion_text":"- Patients with known or suspected succinic semialdehyde dehydrogenase (SSADH) deficiency, given the risk of GHB accumulation due to impaired endogenous metabolism"}
• {"criterion_text":"- Patients receiving opioids or barbiturates at inclusion for non-mechanically ventilated patient"}
• {"criterion_text":"- Patients presenting with hypernatraemia (sodium > 145 mmol/L) or hyperchloraemia (chloride > 110 mmol/L) at inclusion"}
• {"criterion_text":"- Patients with hepatic impairment (Child-Pugh B or C)"}
• {"criterion_text":"- Cardiac conduction disorder"}
• {"criterion_text":"- Obstructive sleep apnea syndrome"}
• {"criterion_text":"- Sodium restriction: Salt intake < 3g/24h"}
• {"criterion_text":"- Deep sedation defined by a RASS score < -2"}
• {"criterion_text":"- Presence of mental confusion: Positive CAM-ICU"}
• {"criterion_text":"- Moribund patient or high likelihood of death within 48 hours"}
• {"criterion_text":"- Legal protection: guardianship, curatorship, or judicial protection"}
• {"criterion_text":"- Patients receiving barbiturates at inclusion"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the duration (in minutes) of deep slow-wave sleep (N3 stage) based on polysomnographic recordings","definition_or_measurement_approach":"Measured by polysomnographic recordings (duration in minutes of N3 stage)"}

Secondary endpoints

• {"endpoint_text":"- 1) Quantity and quality of nocturnal sleep. •Sleep onset latency •\tTotal sleep time •Duration and percentage of N1 stage (sleep onset). •\tDuration and percentage of N2 stage (light slow-wave sleep). •\tPercentage of N3 stage (deep slow-wave sleep). •\tDuration and percentage of Rapid Eye Movement sleep (REM). •\tQuantification of intra-sleep wakefulness. •\tQuantification of atypical sleep. •Quantification of pathological wakefulness •Quantification of micro-awakenings. •\tSleep efficiency","definition_or_measurement_approach":"Evaluated by questionnaire (Richard-Campbell sleep questionnaire) and polysomnography; includes sleep onset latency, total sleep time, stage durations/percentages, intra-sleep wakefulness, atypical sleep, micro-awakenings, sleep efficiency."}
• {"endpoint_text":"- Quality of daytime alertness: •\tDaytime vigilance score (Karolinska Sleepiness scale) •\tAverage sleep latency during the Maintenance of Wakefulness Test (MWT) the morning after the study night","definition_or_measurement_approach":"Daytime vigilance assessed by Karolinska Sleepiness Scale and average sleep latency measured by Maintenance of Wakefulness Test (MWT)."}
• {"endpoint_text":"- Analgesic consumption and participation in rehabilitation: •Morphine equivalent quantification •Assessment of rehabilitation participation","definition_or_measurement_approach":"Analgesic consumption quantified as morphine-equivalent; participation in rehabilitation assessed by predefined participation metrics."}
• {"endpoint_text":"- Evaluation of adverse events, particularly hypokalemia, hypernatremia, mental confusion, agitation, arterial hypertension, or bradycardia","definition_or_measurement_approach":"Assessment and recording of adverse events, with focus on listed events (hypokalemia, hypernatremia, mental confusion, agitation, arterial hypertension, bradycardia)."}

France

Earliest CTIS Part Ii Submission Date

02-04-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

26

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France