GHB: Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.
Placebo: Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18 years or older
2. Hospitalized in the ICU for more than 48 hours
3. Informed consent obtained from the patient
Exclusion Criteria:
1. Unstable patient
2. Known allergy to Gamma-Hydroxybutyrate or any of the excipients
3. Technical impossibility of performing polysomnography
4. Childbearing or Positive pregnancy test for women of childbearing age or breastfeeding
5. Patient who has already received the study treatment
6. History of chronic alcoholism
7. Uncontrolled epilepsy despite appropriate antiepileptic treatment
8. Traumatic brain injury or neurological lesion at risk of epilepsy in the last month
9. Severe hypertension: SBP \> 180 mmHg despite antihypertensive treatment
10. Hypokalemia \< 3.5 mmol/L despite potassium supplementation
11. Bradycardia due to intra-cardiac conduction disorders
12. Obstructive sleep apnea syndrome
13. Sodium restriction: Salt intake \< 3g/24h
14. Patients with known or suspected succinic semialdehyde dehydrogenase (SSADH) deficiency, given the risk of GHB accumulation due to impaired endogenous metabolism.
15. Patients receiving barbiturates at inclusion
16. Patients receiving opioids at inclusion for non-mechanically ventilated patient
17. Patients presenting with hypernatraemia (sodium \> 145 mmol/L) or hyperchloraemia (chloride \> 110 mmol/L) at inclusion
18. Patients with hepatic impairment (Child-Pugh B or C)
19. Deep sedation defined by a RASS score \< -2
20. Presence of mental confusion: Positive CAM-ICU
21. Moribund patient or high likelihood of death within 48 hours
22. Legal protection: guardianship, curatorship, or judicial protection
23. Lack of social security or on AME (state medical aid)
24. Participation in another interventional clinical trial related to the management of sleep disorders, delirium, or sedation in the ICU.
Primary outcome measure(s)
Deep slow-wave sleep — During the night between the day of enrollment (Day0) and the next day (Day 1). The primary endpoint is the duration (in minutes) of deep slow-wave sleep (N3 stage) based on polysomnographic recordings.
Trial sites (1)
Facility
City
Region
Status
Intensive Care Unit, Hospital Pitié Salpêtrière
Paris
Île-de-France Region
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
