Evaluating suvorexant for improving sleep in ICU patients after heart surgery
Effects of the Orexin Receptor Antagonist Suvorexant on Sleep Architecture and Delirium in the Intensive Care Unit: A Multi-Centric Randomized Controlled Trial
This study is testing if a sleep medication called suvorexant can help older patients sleep better and reduce confusion after heart surgery in the ICU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04092894 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of suvorexant, a medication designed to improve sleep, in adult patients aged 60 and older who are recovering from coronary artery bypass graft surgery in the cardiac intensive care unit. Participants will be randomly assigned to receive either suvorexant or a placebo for seven nights following their extubation. The primary focus is to measure nighttime wakefulness after sleep onset using specialized EEG monitoring, alongside assessing total sleep time and the incidence of postoperative delirium. The study aims to provide insights into how suvorexant can enhance sleep quality and reduce delirium in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 and older undergoing elective coronary artery bypass graft surgery.
Not a fit: Patients with severe preoperative cardiac, renal, or liver conditions, or those with significant cognitive impairment or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and reduce the incidence of delirium in elderly patients recovering from cardiac surgery.
How similar studies have performed: Other studies have shown promising results with suvorexant in improving sleep quality, suggesting potential for success in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Montefiore Medical Center/Albert Einstein college of Medicine — Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Matthias Eikermann — Montefiore Medical Center/Albert Einstein College of Medicine
- Study coordinator: Balachundhar Subramaniam
- Email: bsubrama@bidmc.harvard.edu
- Phone: 617-632-7034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.