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Not yet recruiting NCT07596342

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

Phase II Interventional Sleep Disorder (Disorder) Critical Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GHB, Placebo.
Who it may be relevant to
Registry conditions: Sleep Disorder (Disorder), Critical Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Detailed description

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

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.

Primary outcome measures

  • Deep slow-wave sleep [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
Secondary outcome measures (12)
  • Sleep onset latency [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
  • Total sleep time [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
  • Duration of N1 stage [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
  • Percentage of N1 stage [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)]
  • Duration of N2 stage [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
  • Percentage of N2 stage [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)]
  • Percentage of N3 stage [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
  • Duration of Rapid Eye Movement sleep [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
  • Percentage of Rapid Eye Movement sleep [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)]
  • Number of intra-sleep wakefulness. [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
  • Duration of atypical sleep. [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).]
  • Percentage of atypical sleep [Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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 receiving barbiturates at inclusion
  • Patients receiving opioids at inclusion for non-mechanically ventilated patient
  • Patients presenting with hypernatraemia (sodium > 145 mmol/L) or hyperchloraemia (chloride > 110 mmol/L) at inclusion
  • Patients with hepatic impairment (Child-Pugh B or C)
  • Deep sedation defined by a RASS score < -2
  • Presence of mental confusion: Positive CAM-ICU
  • Moribund patient or high likelihood of death within 48 hours
  • Legal protection: guardianship, curatorship, or judicial protection
  • Lack of social security or on AME (state medical aid)
  • Participation in another interventional clinical trial related to the management of sleep disorders, delirium, or sedation in the ICU.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Intensive Care Unit, Hospital Pitié Salpêtrière — Paris

Identifiers

NCT: NCT07596342 · APHP241595 · 2025-521967-11-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗