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NOT YET RECRUITING
NCT07596342
PHASE2

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients: A Pilot Double-Blind Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-06

Completion Date

2027-10

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

GHB

Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.

DRUG

Placebo

Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.

Locations (1)

Intensive Care Unit, Hospital Pitié Salpêtrière

Paris, Île-de-France Region, France