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

Phase 2Not Yet RecruitingNCT07596342

Assistance Publique - Hôpitaux de Paris24 enrolled

Overview

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.

In intensive care, sleep disturbances are extremely common and represent a major source of discomfort for patients. While the total duration of sleep is minimally affected, deep slow-wave sleep (N3) is significantly underrepresented. 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 with benzodiazepines or propofol 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 reduce sleep onset latency, increase deep slow-wave sleep (N3), improve sleep quality, and enhance daytime alertness scores. 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. The primary objective of this pilot study is to show that the intravenous administration of GHB improves the duration (in minutes) of deep slow-wave sleep (N3 stage) in critically ill adult patients compared to a placebo

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Deep slow-wave sleep

The primary endpoint is the duration (in minutes) of deep slow-wave sleep (N3 stage) based on polysomnographic recordings.