COMPLETED

Suvorexant and Sleep/Delirium in ICU Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-02-28
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04092894

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 60 years or older
  2. 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. 1. Preoperative left ventricular ejection fraction of less than 30%
  2. 2. Renal failure (creatinine \>2 mg/dl or dialysis dependence)
  3. 3. Liver failure (CHILD-Pugh\>4)
  4. 4. Coma (RASS\<-1)
  5. 5. Signs and symptoms of delirium and agitation at time of enrollment (CAM-ICU positive)
  6. 6. Montreal Cognitive Assessment (MoCA) below 23 at time of consent
  7. 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. 8. Severe sleep apnea requiring home continuous positive airway pressure treatment
  9. 9. Morbid obesity (BMI \>40)
  10. 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. 11. Patients with known hypersensitivity to study medications
  12. 12. English language limitations (Sleep assessment and delirium assessment tools are only validated in English)
  13. 13. Patients enrolled in other interventional studies which could confound the primary endpoint.

Contacts and Locations

Principal Investigator

Matthias Eikermann
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center/Albert Einstein College of Medicine
Balachundhar Subramaniam
PRINCIPAL_INVESTIGATOR
Beths Israel Deaconess Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-28
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2020-02-28
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • Suvorexant
  • Sleep architecture
  • Delirium
  • Intensive care unit

Additional Relevant MeSH Terms

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