Suvorexant and Sleep/Delirium in ICU Patients

Description

Investigators will evaluate the efficacy of postoperative oral suvorexant treatment on nighttime wakefulness after persistent sleep onset (WASO) among adult cardiac surgical patients recovering in the cardiac intensive care unit (ICU). The study include patients ≥ 60 years old undergoing coronary artery bypass graft surgery (CABG), with or without valve surgery (aortic or mitral). Patients will receive either oral suvorexant or placebo for 7 nights starting the night after extubation. The primary hypothesis is that suvorexant compared with placebo decreases WASO, as measured by a specialized electroencephalogram (EEG), the SedLine monitor, during the first night in the cardiac ICU. Investigators will also assess total sleep time (TST), time to sleep onset (TSO), and postoperative delirium and delirium-free days.

Conditions

Insomnia, Sleep Fragmentation, Sleep Initiation and Maintenance Disorders, Postoperative Delirium

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Study Overview

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Study Details

Study overview

Investigators will evaluate the efficacy of postoperative oral suvorexant treatment on nighttime wakefulness after persistent sleep onset (WASO) among adult cardiac surgical patients recovering in the cardiac intensive care unit (ICU). The study include patients ≥ 60 years old undergoing coronary artery bypass graft surgery (CABG), with or without valve surgery (aortic or mitral). Patients will receive either oral suvorexant or placebo for 7 nights starting the night after extubation. The primary hypothesis is that suvorexant compared with placebo decreases WASO, as measured by a specialized electroencephalogram (EEG), the SedLine monitor, during the first night in the cardiac ICU. Investigators will also assess total sleep time (TST), time to sleep onset (TSO), and postoperative delirium and delirium-free days.

Effects of the Orexin Receptor Antagonist Suvorexant on Sleep Architecture and Delirium in the Intensive Care Unit: A Multi-Centric Randomized Controlled Trial

Suvorexant and Sleep/Delirium in ICU Patients

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02115

Bronx

Montefiore Medical Center/Albert Einstein college of Medicine, Bronx, New York, United States, 10467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Beth Israel Deaconess Medical Center,

Matthias Eikermann, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center/Albert Einstein College of Medicine

Balachundhar Subramaniam, PRINCIPAL_INVESTIGATOR, Beths Israel Deaconess Medical Center

Study Record Dates

2025-07-01