Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients: A Pilot Double-Blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 24
- Locations
- 1
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: GHB (Drug)
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Not specified
Secondary Outcomes
- Self-assessment questionnaire of the quality of sleep(On the day after enrollment ( Day 1))
- Hetero-evaluation questionnaire of the quality of sleep(On the day after enrollment ( Day 1))
- Daytime vigilance score(On the day after enrollment ( Day 1))
- Participation in rehabilitation(From the day after enrollment (Day 1) to two days after enrollment (Day 2))