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

20. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

24

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: GHB
Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.
Placebo-Komparator: 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.
Arzneimittel: Placebo
Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Deep slow-wave sleep
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sleep onset latency
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: On the day after enrollment ( Day 1)
On the day after enrollment ( Day 1)
Analgesic consumption
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Assistance Publique - Hôpitaux de Paris

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • APHP241595
  • 2025-521967-11-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Zeitrahmen

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-Zugriffskriterien

Researchers who provide a methodologically sound proposal

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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