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Can a sleep drug prevent ICU delirium in older heart patients?

NCT ID NCT04092894

Symptom relief Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the sleep medication suvorexant (Belsomra) can help older adults sleep better and reduce confusion after heart surgery. One hundred patients aged 60 and older received either suvorexant or a placebo for seven nights in the ICU. Researchers measured sleep quality with brain monitors and tracked episodes of delirium.

What this could mean

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

Active substance
suvorexant (Belsomra)
What this could lead to
If it works, this could point toward a way to improve sleep and reduce confusion after heart surgery in older adults.
What could go wrong
This is a small, early-phase trial with only 100 participants. The results may not apply to all ICU patients, and suvorexant may cause side effects like daytime drowsiness.

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

100 people

The number who actually took part.

Started

Feb 2020

Finished

Jul 2025

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

60 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. Age 60 years or older 2. Undergoing elective coronary artery bypass graft surgery with or without aortic and/or mitral valve replacement, who are expected to be transferred to the ICU postoperatively Exclusion criteria: 1. Preoperative left ventricular ejection fraction of less than 30% 2. Renal failure (creatinine \>2 mg/dl or dialysis dependence) 3. Liver failure (CHILD-Pugh\>4) 4. Coma (RASS\<-1) 5. Signs and symptoms of delirium and agitation at time of enrollment (CAM-ICU positive) 6. Montreal Cognitive Assessment (MoCA) below 23 at time of consent 7. Psychiatric or neurologic diseases (including chronic benzodiazepine use, bipolar disorder, psychotic disorder, posttraumatic stress disorder, requirement of prophylactic psychiatric medication, evidence of acute depression on screening visit, preexisting cognitive impairment, Alzheimer disease, Parkinson's disease, medications for cognitive decline, history of recent seizures (within 1 year prior visit), alcoholism or documented history of alcohol abuse, and narcolepsy) 8. Severe sleep apnea requiring home continuous positive airway pressure treatment 9. Morbid obesity (BMI \>40) 10. Known or suspected pregnancy (there are no adequate and well-controlled studies of suvorexant in pregnant women. Based on animal data, Suvorexant may cause fetal harm). 11. Patients with known hypersensitivity to study medications 12. English language limitations (Sleep assessment and delirium assessment tools are only validated in English) 13. Patients enrolled in other interventional studies which could confound the primary endpoint.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder delirium Emergence Delirium insomnia Sleep Deprivation sleep disorder, initiating and maintaining sleep

As listed by the trial registrant

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

Insomnia Postoperative delirium Sleep fragmentation Sleep initiation and maintenance disorders

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115, United States

  • Montefiore Medical Center/Albert Einstein college of Medicine

    The Bronx, New York, 10467, United States

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