Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients (GAMMA-SLEEP)
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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Florian Blanchard, MD
- 電話番号：+ 33184828065
- メール：florian.blanchard@aphp.fr
研究場所
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Île-de-France Region
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Paris、Île-de-France Region、フランス、75013
- Intensive Care Unit, Hospital Pitié Salpêtrière
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コンタクト：
- Florian Blanchard, MD
- 電話番号：+ 33184828065
- メール：florian.blanchard@aphp.fr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.
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プラセボコンパレーター：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.
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Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Deep slow-wave sleep
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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The primary endpoint is the duration (in minutes) of deep slow-wave sleep (N3 stage) based on polysomnographic recordings.
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sleep onset latency
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Total sleep time
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Duration of N1 stage
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Percentage of N1 stage
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1)
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During the night between the day of enrollment (Day0) and the next day (Day 1)
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Duration of N2 stage
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Percentage of N2 stage
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1)
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During the night between the day of enrollment (Day0) and the next day (Day 1)
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Percentage of N3 stage
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Duration of Rapid Eye Movement sleep
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Percentage of Rapid Eye Movement sleep
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1)
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During the night between the day of enrollment (Day0) and the next day (Day 1)
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Number of intra-sleep wakefulness.
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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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.
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Duration of atypical sleep.
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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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
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Percentage of atypical sleep
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1)
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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
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During the night between the day of enrollment (Day0) and the next day (Day 1)
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Duration of pathological wakefulness
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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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
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Percentage of pathological wakefulness
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1)
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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
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During the night between the day of enrollment (Day0) and the next day (Day 1)
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Number of micro-awakenings.
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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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.
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Sleep efficiency
時間枠：During the night between the day of enrollment (Day0) and the next day (Day 1).
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is defined as total sleep time relative to the sleep period (corresponding to total sleep time + intra-sleep wakefulness).
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During the night between the day of enrollment (Day0) and the next day (Day 1).
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Average sleep latency during the Maintenance of Wakefulness Test
時間枠：On the day after enrollment ( Day 1)
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On the day after enrollment ( Day 1)
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Analgesic consumption
時間枠：From the day after enrollment (Day 1) to two days after enrollment (Day 2)
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Morphine equivalent quantification of analgesic consumption (mg) over the 24 hours following the study night.
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From the day after enrollment (Day 1) to two days after enrollment (Day 2)
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Adverse event assessment
時間枠：From the day of enrollment (Day 0) to the end of follow-up (Day 2)
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All adverse events will be recorded during the study with special attention to potential side effects of GHB
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From the day of enrollment (Day 0) to the end of follow-up (Day 2)
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Self-assessment questionnaire of the quality of sleep
時間枠：On the day after enrollment ( Day 1)
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Questionnaire of the quality of sleep :Richard-Campbell Sleep Questionnaire.
min : 0 max : 100 Higher is a better outcome
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On the day after enrollment ( Day 1)
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Hetero-evaluation questionnaire of the quality of sleep
時間枠：On the day after enrollment ( Day 1)
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min : 0 max : 4 Higher is a worse outcome
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On the day after enrollment ( Day 1)
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Daytime vigilance score
時間枠：On the day after enrollment ( Day 1)
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Karolinska Sleepiness scale min : 1 max : 9 Higher is a worse outcome
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On the day after enrollment ( Day 1)
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Participation in rehabilitation
時間枠：From the day after enrollment (Day 1) to two days after enrollment (Day 2)
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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)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- APHP241595
- 2025-521967-11-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
クリティカルケアの臨床試験
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Washington University School of MedicineColumbia University; Indiana University; Rakai Health Sciences Program; Reach the Youth Uganda完了コントロールアーム_Bolstered Care | 治療アーム_HIVRR+S+FL | 治療ARM_HIVRR+S+FL+Mウガンダ
GHBの臨床試験
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University of ZurichUniversity of Vienna; University of Salerno; University of Freiburg; University of Regensburg完了
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Laboratorio Farmaceutico Ct S.r.l.完了アルコール依存症 | アルコール使用障害 (AUD)
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Fundación FLS de Lucha Contra el Sida, las Enfermedades...完了
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Catholic University of the Sacred HeartMedical University of Vienna; University of Bologna; CT Pharmaceutical Industries, Sanremo - Italy完了