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

NCT07596342 | Not Yet Recruiting Phase 2

• 2 other identifiers: APHP2415952025-521967-11-00
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gamma-hydroxybutyrate; Sleep disorder; ICU; Slow-wave sleep

Outcome Measures

Primary Outcomes (1)

• Deep slow-wave sleep

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

  During the night between the day of enrollment (Day0) and the next day (Day 1).

Secondary Outcomes (23)

• Sleep onset latency

  During the night between the day of enrollment (Day0) and the next day (Day 1).

• Total sleep time

  During the night between the day of enrollment (Day0) and the next day (Day 1).

• Duration of N1 stage

  During the night between the day of enrollment (Day0) and the next day (Day 1).

• Percentage of N1 stage

  During the night between the day of enrollment (Day0) and the next day (Day 1)

• Duration of N2 stage

  During the night between the day of enrollment (Day0) and the next day (Day 1).

Study Arms (2)

GHB

EXPERIMENTAL

Intravenous GHB (Gamma-OH) will be administered at a dose of 15 mg/kg as induction over 20 minutes (in a 100 mL NaCl bag), followed by a continuous infusion of 10 mg/kg/h over 8 hours (via an electric syringe pump) from 10:00 PM to 6:00 AM for one night.

Drug: GHB

Control

PLACEBO COMPARATOR

A placebo in the form of 0.9% NaCl (as Gamma-OH is transparent and completely soluble), administered intravenously as a induction (after a dilution in a 100 mL NaCl bag) and then continuously (without dilution via an electric syringe pump) for 8 hours from 10:00 PM to 6:00 AM for one night.

Drug: Placebo

Interventions

GHB DRUG

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

GHB

Placebo DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Hospitalized in the ICU for more than 48 hours
• Informed consent obtained from the patient

You may not qualify if:

• Unstable patient
• Known allergy to Gamma-Hydroxybutyrate or any of the excipients
• Technical impossibility of performing polysomnography
• Childbearing or Positive pregnancy test for women of childbearing age or breastfeeding
• Patient who has already received the study treatment
• History of chronic alcoholism
• Uncontrolled epilepsy despite appropriate antiepileptic treatment
• Traumatic brain injury or neurological lesion at risk of epilepsy in the last month
• Severe hypertension: SBP \> 180 mmHg despite antihypertensive treatment
• Hypokalemia \< 3.5 mmol/L despite potassium supplementation
• Bradycardia due to intra-cardiac conduction disorders
• Obstructive sleep apnea syndrome
• Sodium restriction: Salt intake \< 3g/24h
• Patients with known or suspected succinic semialdehyde dehydrogenase (SSADH) deficiency, given the risk of GHB accumulation due to impaired endogenous metabolism.
• Patients with hepatic impairment (Child-Pugh B or C)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Intensive Care Unit, Hospital Pitié Salpêtrière

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Florian Blanchard, MD

CONTACT

+ 33184828065; florian.blanchard@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 19, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)