Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients (GAMMA-SLEEP)

May 20, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75013
        • Intensive Care Unit, Hospital Pitié Salpêtrière
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older
  2. Hospitalized in the ICU for more than 48 hours
  3. Informed consent obtained from the patient

Exclusion Criteria:

  1. Unstable patient
  2. Known allergy to Gamma-Hydroxybutyrate or any of the excipients
  3. Technical impossibility of performing polysomnography
  4. Childbearing or Positive pregnancy test for women of childbearing age or breastfeeding
  5. Patient who has already received the study treatment
  6. History of chronic alcoholism
  7. Uncontrolled epilepsy despite appropriate antiepileptic treatment
  8. Traumatic brain injury or neurological lesion at risk of epilepsy in the last month
  9. Severe hypertension: SBP > 180 mmHg despite antihypertensive treatment
  10. Hypokalemia < 3.5 mmol/L despite potassium supplementation
  11. Bradycardia due to intra-cardiac conduction disorders
  12. Obstructive sleep apnea syndrome
  13. Sodium restriction: Salt intake < 3g/24h
  14. Patients with known or suspected succinic semialdehyde dehydrogenase (SSADH) deficiency, given the risk of GHB accumulation due to impaired endogenous metabolism.
  15. Patients receiving barbiturates at inclusion
  16. Patients receiving opioids at inclusion for non-mechanically ventilated patient
  17. Patients presenting with hypernatraemia (sodium > 145 mmol/L) or hyperchloraemia (chloride > 110 mmol/L) at inclusion
  18. Patients with hepatic impairment (Child-Pugh B or C)
  19. Deep sedation defined by a RASS score < -2
  20. Presence of mental confusion: Positive CAM-ICU
  21. Moribund patient or high likelihood of death within 48 hours
  22. Legal protection: guardianship, curatorship, or judicial protection
  23. Lack of social security or on AME (state medical aid)
  24. Participation in another interventional clinical trial related to the management of sleep disorders, delirium, or sedation in the ICU.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GHB
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
Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.
Placebo Comparator: Control
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
Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Deep slow-wave sleep
Time Frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep onset latency
Time Frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
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).
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).
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)
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).
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)
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).
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).
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)
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).
Intra-sleep wakefulness is defined as a period of wakefulness between sleep phases. The quantification of intra-sleep wakefulness corresponds to the number of awakenings during the night.
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).
Duration of atypical sleep relative to the total sleep time. Atypical sleep is defined as slow-wave sleep equivalent to N2 stage but without sleep spindles or K-complexes
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)
Percentage of atypical sleep relative to the total sleep time. Atypical sleep is defined as slow-wave sleep equivalent to N2 stage but without sleep spindles or K-complexes
During the night between the day of enrollment (Day0) and the next day (Day 1)
Duration of pathological wakefulness
Time Frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Duration of pathological wakefulness relative to the total sleep time is defined as rapid eye movements and chin EMG activity associated with slow delta wave EEG activity
During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of pathological wakefulness
Time Frame: During the night between the day of enrollment (Day0) and the next day (Day 1)
Percentage of pathological wakefulness relative to the total sleep time is defined as rapid eye movements and chin EMG activity associated with slow delta wave EEG activity
During the night between the day of enrollment (Day0) and the next day (Day 1)
Number of micro-awakenings.
Time Frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Micro-awakenings are defined as an abrupt change in EEG frequency (fromdelta-theta to theta-alpha) lasting 3 to 15 seconds in a patient who has been asleep for more than 10 seconds, with or without an increase in chin EMG activity during slow-wave sleep and with an activation lasting more than one second during REM sleep.
During the night between the day of enrollment (Day0) and the next day (Day 1).
Sleep efficiency
Time Frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
is defined as total sleep time relative to the sleep period (corresponding to total sleep time + intra-sleep wakefulness).
During the night between the day of enrollment (Day0) and the next day (Day 1).
Average sleep latency during the Maintenance of Wakefulness Test
Time Frame: On the day after enrollment ( Day 1)
On the day after enrollment ( Day 1)
Analgesic consumption
Time Frame: From the day after enrollment (Day 1) to two days after enrollment (Day 2)
Morphine equivalent quantification of analgesic consumption (mg) over the 24 hours following the study night.
From the day after enrollment (Day 1) to two days after enrollment (Day 2)
Adverse event assessment
Time Frame: From the day of enrollment (Day 0) to the end of follow-up (Day 2)
All adverse events will be recorded during the study with special attention to potential side effects of GHB
From the day of enrollment (Day 0) to the end of follow-up (Day 2)
Self-assessment questionnaire of the quality of sleep
Time Frame: On the day after enrollment ( Day 1)
Questionnaire of the quality of sleep :Richard-Campbell Sleep Questionnaire. min : 0 max : 100 Higher is a better outcome
On the day after enrollment ( Day 1)
Hetero-evaluation questionnaire of the quality of sleep
Time Frame: On the day after enrollment ( Day 1)
min : 0 max : 4 Higher is a worse outcome
On the day after enrollment ( Day 1)
Daytime vigilance score
Time Frame: On the day after enrollment ( Day 1)
Karolinska Sleepiness scale min : 1 max : 9 Higher is a worse outcome
On the day after enrollment ( Day 1)
Participation in rehabilitation
Time Frame: From the day after enrollment (Day 1) to two days after enrollment (Day 2)

Assessment of rehabilitation participation by the physiotherapy team using a visual analog scale.

min : 0 max : 100 Higher is a better outcome
From the day after enrollment (Day 1) to two days after enrollment (Day 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP241595
  • 2025-521967-11-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

IPD Sharing 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

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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