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Can a narcolepsy drug fix ICU sleep problems?

NCT ID NCT07596342

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a drug called gamma-hydroxybutyrate (GHB) can help intensive care patients get better deep sleep. Sleep problems are very common in the ICU and can lead to serious issues like confusion and longer recovery. The trial will give GHB or a placebo to 24 adults in the ICU and measure their sleep quality using brain wave recordings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gamma-hydroxybutyrate (GHB)
What this could lead to
If it works, this could provide a new way to improve restorative sleep in ICU patients, potentially reducing complications like delirium and difficulty weaning from ventilation.
What could go wrong
This is a small pilot study with only 24 participants, so results may not apply broadly. GHB can have side effects like dizziness or dependence, and its safety in critically ill patients is not fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Intensive Care Unit, Hospital Pitié Salpêtrière

    Paris, Île-de-France Region, 75013, France

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Other studies related to the condition(s) this trial covers.