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

NCT07596342 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • Sleep Disorder (Disorder)
  • Critical Care

Interventions

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.

DRUG

GHB

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07596342 on ClinicalTrials.gov