Suvorexant for Sleep Disorders in ICU Patients
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using chronic benzodiazepines or medications for cognitive decline, you may not be eligible to participate.
What data supports the effectiveness of the drug Suvorexant for sleep disorders in ICU patients?
How is the drug suvorexant unique for treating sleep disorders in ICU patients?
Suvorexant is unique because it works by blocking orexin receptors, which are involved in wakefulness, helping to promote sleep without the deliriogenic effects that other sleep-promoting agents might have. This makes it potentially beneficial for ICU patients who often experience insomnia and delirium.12346
Research Team
Balachundhar Subramaniam, M.D.
Principal Investigator
Beths Israel Deaconess Medical Center
Matthias Eikermann, MD, PHD
Principal Investigator
Montefiore Medical Center/Albert Einstein College of Medicine
Eligibility Criteria
This trial is for adults over 60 who are recovering from coronary artery bypass graft surgery in the ICU. They must speak English and not have severe obesity, known pregnancy, significant heart or kidney failure, liver failure, coma, delirium at enrollment time, certain cognitive impairments or psychiatric conditions.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants complete the Richards-Campbell Sleep Questionnaire (RCSQ) every morning
Treatment
Participants receive either suvorexant or placebo for 7 nights starting the night after extubation
Follow-up
Participants are monitored for postoperative delirium and sleep quality until hospital discharge
Treatment Details
Interventions
- Placebo oral tablet (Behavioural Intervention)
- Suvorexant (Orexin Receptor Antagonist)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor