Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Sleep Disorder (Disorder), Critical Care

In brief

In intensive care, sleep disturbances are extremely common and represent a major source of discomfort for patients. Restorative sleep is very limited. Beyond being the primary source of discomfort reported by patients, these sleep disturbances are associated with difficulties in weaning from mechanical ventilation, an increased risk of delirium, and potentially higher mortality. Traditional treatments artificially increase the total duration of sleep but lead to disrupted sleep architecture. Gamma-hydroxybutyrate (GHB) is currently used for several sleep disorders, such as narcolepsy, due to its ability to increase restorative sleep. This medication has been used for years as a sedative in intensive care. Despite these potential benefits, the efficacy of GHB has never been evaluated for sleep disturbances in intensive care settings. This study focuses on evaluating the effectiveness of intravenous Gamma-hydroxybutyrate (GHB) in the treatment of sleep disorders in intensive care.

Key facts

Study ID

NCT07596342

Run by

Assistance Publique - Hôpitaux de Paris

People needed

24

Starts

2026-06-01

Expected to finish

2027-10-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or older
• Hospitalized in the ICU for more than 48 hours
• Informed consent obtained from the patient

You may not qualify if…

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

Where it is running

• Intensive Care Unit, Hospital Pitié Salpêtrière — Paris, Île-de-France Region, France

Full record on ClinicalTrials.gov

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