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

20. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Odhadovaný)

24

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: GHB
Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.
Komparátor placeba: 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.
Lék: Placebo
Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Deep slow-wave sleep
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sleep onset latency
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: On the day after enrollment ( Day 1)
On the day after enrollment ( Day 1)
Analgesic consumption
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Assistance Publique - Hôpitaux de Paris

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. října 2027

Dokončení studie (Odhadovaný)

1. října 2027

Termíny zápisu do studia

První předloženo

30. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

12. května 2026

První zveřejněno (Aktuální)

19. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

Kritéria přístupu pro sdílení IPD

Researchers who provide a methodologically sound proposal

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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