Electrophysiological analysis of Gamma-Hydroxybutyrate-induced sleep in intensive care patients: A Pilot Double-Blind Randomized Controlled Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2026-04-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Assistance Publique des Hôpitaux de Paris

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

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

Secondary objectives 4

1. The secondary objectives are to compare intravenous GHB to a placebo in terms: Quantity and quality of nocturnal sleep
2. The secondary objectives are to compare intravenous GHB to a placebo in terms of quality of daytime alertness
3. The secondary objectives are to compare intravenous GHB to a placebo in terms of painkiller consumption and participation in rehabilitation
4. The secondary objectives are to compare intravenous GHB to a placebo in terms of adverse events

Conditions and MedDRA coding

The study population includes adult ICU patients with a hospitalization of more than 48 hours. We have chosen to include patients with or without mechanical ventilation, as sleep disorders affect all ICU patients after 48 hours.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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 24

1. Unstable patient
2. Lack of social security or on AME (state medical aid)
3. Participation in another interventional clinical trial related to the management of sleep disorders, delirium, or sedation in the ICU.
4. Known allergy to Gamma-Hydroxybutyrate or any of the exipients
5. Technical impossibility of performing polysomnography
6. Positive pregnancy test for women of childbearing age or breastfeeding
7. Patient already included in this study
8. History of chronic alcoholism
9. Uncontrolled epilepsy despite appropriate antiepileptic treatment
10. Recent head trauma or neurological injury
11. Severe hypertension: SBP > 180 mmHg despite antihypertensive treatment
12. Hypokalemia < 3.5 mmol/L despite potassium supplementation
13. Patients with known or suspected succinic semialdehyde dehydrogenase (SSADH) deficiency, given the risk of GHB accumulation due to impaired endogenous metabolism
14. Patients receiving opioids or barbiturates at inclusion for non-mechanically ventilated patient
15. Patients presenting with hypernatraemia (sodium > 145 mmol/L) or hyperchloraemia (chloride > 110 mmol/L) at inclusion
16. Patients with hepatic impairment (Child-Pugh B or C)
17. Cardiac conduction disorder
18. Obstructive sleep apnea syndrome
19. Sodium restriction: Salt intake < 3g/24h
20. Deep sedation defined by a RASS score < -2
21. Presence of mental confusion: Positive CAM-ICU
22. Moribund patient or high likelihood of death within 48 hours
23. Legal protection: guardianship, curatorship, or judicial protection
24. Patients receiving barbiturates at inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the duration (in minutes) of deep slow-wave sleep (N3 stage) based on polysomnographic recordings

Secondary endpoints 4

1. 1) Quantity and quality of nocturnal sleep. •Sleep onset latency • Total sleep time •Duration and percentage of N1 stage (sleep onset). • Duration and percentage of N2 stage (light slow-wave sleep). • Percentage of N3 stage (deep slow-wave sleep). • Duration and percentage of Rapid Eye Movement sleep (REM). • Quantification of intra-sleep wakefulness. • Quantification of atypical sleep. •Quantification of pathological wakefulness •Quantification of micro-awakenings. • Sleep efficiency
2. Quality of daytime alertness: • Daytime vigilance score (Karolinska Sleepiness scale) • Average sleep latency during the Maintenance of Wakefulness Test (MWT) the morning after the study night
3. Analgesic consumption and participation in rehabilitation: •Morphine equivalent quantification •Assessment of rehabilitation participation
4. Evaluation of adverse events, particularly hypokalemia, hypernatremia, mental confusion, agitation, arterial hypertension, or bradycardia

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Florian BLANCHARD

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

BEN ABDESSELAM

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications