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.
研究概览
详细说明
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
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Florian Blanchard, MD
- 电话号码：+ 33184828065
- 邮箱：florian.blanchard@aphp.fr
学习地点
-
-
Île-de-France Region
-
Paris、Île-de-France Region、法国、75013
- Intensive Care Unit, Hospital Pitié Salpêtrière
-
接触：
- Florian Blanchard, MD
- 电话号码：+ 33184828065
- 邮箱：florian.blanchard@aphp.fr
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.
|
|
安慰剂比较：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.
|
Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Deep slow-wave sleep
大体时间：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).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sleep onset latency
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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
大体时间：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
大体时间：On the day after enrollment ( Day 1)
|
On the day after enrollment ( Day 1)
|
|
|
Analgesic consumption
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- APHP241595
- 2025-521967-11-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.