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Can a new sleep aid keep ICU patients from becoming delirious?

NCT ID NCT07407400

Symptom relief Sponsor: Mahidol University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a sleep medication called lemborexant can help older adults in the intensive care unit (ICU) sleep better and reduce their risk of delirium, a state of sudden confusion. The trial will involve 100 patients aged 65 and older who are in the surgical ICU. Participants will receive either lemborexant or a placebo for three nights, and researchers will measure sleep quality and delirium rates.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

65 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: * Age 65 years or older. * Admission to the Surgical Intensive Care Unit (SICU). * Anticipated ICU stay of at least 48 hours, as assessed by the ICU consultant and responsible surgeon. * Able to receive enteral medication via oral or nasogastric route. Exclusion Criteria: * Requirement for frequent neurological checks or scheduled awakening (e.g., acute stroke or neurosurgery). * Deep sedation defined as Richmond Agitation-Sedation Scale (RASS) ≤ -3. * Positive Confusion Assessment Method for the ICU (CAM-ICU) within 12 hours prior to randomization. * Severe hemodynamic or respiratory instability requiring neuromuscular blockers or high-dose vasopressors (e.g., norepinephrine ≥ 0.1 µg/kg/min and titrating upward). * High risk of aspiration, including ongoing vomiting, gastric residual volume \>250 mL, or intolerance to oral or enteral medications. * Concomitant use of strong CYP3A inhibitors or inducers (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, rifampicin, carbamazepine, phenytoin, or St. John's wort). * Severe hepatic impairment (Child-Pugh class C). * End-stage kidney disease or chronic kidney disease stage 5. * Concomitant use of sedative-hypnotic medications, including benzodiazepines, Z-drugs, trazodone, tricyclic antidepressants, melatonin, or other sleep-inducing agents. * Known hypersensitivity to lemborexant or other dual orexin receptor antagonists. * History of cataplexy-like symptoms or severe depression with suicidal ideation.

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Conditions

The condition(s) this trial relates to.

Critical Illness delirium Parasomnias sleep disorder

As listed by the trial registrant

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

Critical illness Delirium Sleep disturbance

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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