Sleep Disorder (Disorder)Phase 2GAMMA-SLEEPNCT07596342
Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients
A Phase 2 study testing GHB in people with Sleep Disorder (Disorder) and Critical Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder (Disorder), Critical Care
- What is being tested?
- GHB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Hospitalized in the ICU for more than 48 hours
- Informed consent obtained from the patient
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Intensive Care Unit, Hospital Pitié Salpêtrière
Paris, Île-de-France Region, 75013
Florian Blanchard, MD, + 33184828065, florian.blanchard@aphp.fr
About this study
Official title: 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.
Read the 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
- Conditions
- Sleep Disorder (Disorder), Critical Care
- Being tested
- GHB, Placebo
- Keywords
- Gamma-hydroxybutyrate, Sleep disorder, ICU, Slow-wave sleep
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GHBDrug
Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.
PlaceboDrug
Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| GHB | Experimental | 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. Receives: Drug: GHB |
| Control | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep slow-wave sleep
The primary endpoint is the duration (in minutes) of deep slow-wave sleep (N3 stage) based on polysomnographic recordings.
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Secondary outcomes (23)
Sleep onset latency
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Total sleep time
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Duration of N1 stage
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of N1 stage
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1)
Duration of N2 stage
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of N2 stage
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1)
Percentage of N3 stage
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Duration of Rapid Eye Movement sleep
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of Rapid Eye Movement sleep
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1)
Number of intra-sleep wakefulness.
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.
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Duration of atypical sleep.
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
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of atypical sleep
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
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1)
Duration of pathological wakefulness
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
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of pathological wakefulness
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
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1)
Number of micro-awakenings.
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.
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Sleep efficiency
is defined as total sleep time relative to the sleep period (corresponding to total sleep time + intra-sleep wakefulness).
Measured: During the night between the day of enrollment (Day0) and the next day (Day 1).
Self-assessment questionnaire of the quality of sleep
Questionnaire of the quality of sleep :Richard-Campbell Sleep Questionnaire. min : 0 max : 100 Higher is a better outcome
Measured: On the day after enrollment ( Day 1)
Hetero-evaluation questionnaire of the quality of sleep
min : 0 max : 4 Higher is a worse outcome
Measured: On the day after enrollment ( Day 1)
Daytime vigilance score
Karolinska Sleepiness scale min : 1 max : 9 Higher is a worse outcome
Measured: On the day after enrollment ( Day 1)
Average sleep latency during the Maintenance of Wakefulness Test
Measured: On the day after enrollment ( Day 1)
Analgesic consumption
Morphine equivalent quantification of analgesic consumption (mg) over the 24 hours following the study night.
Measured: From the day after enrollment (Day 1) to two days after enrollment (Day 2)
Participation in rehabilitation
Assessment of rehabilitation participation by the physiotherapy team using a visual analog scale.
min : 0 max : 100 Higher is a better outcome
Measured: From the day after enrollment (Day 1) to two days after enrollment (Day 2)
Adverse event assessment
All adverse events will be recorded during the study with special attention to potential side effects of GHB
Measured: From the day of enrollment (Day 0) to the end of follow-up (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596342
- Sponsor's protocol ID
- APHP241595
- Other IDs
- 2025-521967-11-00, 2025
- Acronym
- GAMMA-SLEEP
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients: A Pilot Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07596342
- Acronym / sponsor ID
- GAMMA-SLEEP / APHP241595
- Conditions
- Sleep Disorder (Disorder), Critical Care
- Keywords
- Gamma-hydroxybutyrate, Sleep disorder, ICU, Slow-wave sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GHB | Experimental | Drug: GHBIntravenous 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. |
| Control | Placebo comparator | Drug: PlaceboA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Hospitalized in the ICU for more than 48 hours
- Informed consent obtained from the patient
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GHBAdministration of GHB intravenously with a induction followed by a maintenance dose for 8 hours. | Drug | GHB |
| PlaceboAdministration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours. | Drug | Control |
Primary outcome
Deep slow-wave sleep
Time frame: 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.
23 secondary outcomes
Sleep onset latency
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Total sleep time
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Duration of N1 stage
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of N1 stage
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)
Duration of N2 stage
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of N2 stage
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)
Percentage of N3 stage
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Duration of Rapid Eye Movement sleep
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of Rapid Eye Movement sleep
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)
Number of intra-sleep wakefulness.
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Duration of atypical sleep.
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of atypical sleep
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)
Duration of pathological wakefulness
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Percentage of pathological wakefulness
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1)
Number of micro-awakenings.
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Sleep efficiency
Time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).
Self-assessment questionnaire of the quality of sleep
Time frame: On the day after enrollment ( Day 1)
Hetero-evaluation questionnaire of the quality of sleep
Time frame: On the day after enrollment ( Day 1)
Daytime vigilance score
Time frame: On the day after enrollment ( Day 1)
Average sleep latency during the Maintenance of Wakefulness Test
Time frame: On the day after enrollment ( Day 1)
Analgesic consumption
Time frame: From the day after enrollment (Day 1) to two days after enrollment (Day 2)
Participation in rehabilitation
Time frame: From the day after enrollment (Day 1) to two days after enrollment (Day 2)
Adverse event assessment
Time frame: From the day of enrollment (Day 0) to the end of follow-up (Day 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GHB in people with Sleep Disorder (Disorder) and Critical Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Blanchard, MD (+ 33184828065, florian.blanchard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep slow-wave sleep (time frame: During the night between the day of enrollment (Day0) and the next day (Day 1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.