Clinical Trial

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

Study acronym: GAMMA-SLEEP
Not Yet Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-12.
Trial Details
NCT Number NCT07596342
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Sleep Disorder (Disorder), Critical Care
Enrollment 24 participants
Start Date 2026-06
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-22