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Suvorexant for Sleep Disorders in ICU Patients
Phase 4
Recruiting
Led By Matthias Eikermann, MD, PhD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 60 years or older
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
Must not have
Montreal Cognitive Assessment (MoCA) below 23 at time of consent
Severe sleep apnea requiring home continuous positive airway pressure treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first night after extubation between 11:00pm and 6:00am
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing whether the sleep drug suvorexant can help decrease wakefulness after surgery in elderly patients in the ICU.
Who is the study for?
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.
What is being tested?
The study tests if suvorexant can improve sleep after surgery by reducing wakefulness during the night. Participants will receive either suvorexant or a placebo for seven nights post-extubation. Sleep quality will be monitored using EEG technology to measure various sleep parameters.
What are the potential side effects?
Suvorexant may cause side effects such as daytime drowsiness, dizziness upon standing (which could lead to falls), altered mental state or mood changes like depression and suicidal thoughts in rare cases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
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I am scheduled for heart bypass or valve surgery and will be in the ICU afterwards.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cognitive test score was below 23.
Select...
I use a CPAP machine for severe sleep apnea.
Select...
I do not have severe kidney problems or need dialysis.
Select...
I am currently experiencing confusion and restlessness.
Select...
I am not in a coma.
Select...
My liver is functioning well (CHILD-Pugh ≤ 4).
Select...
My BMI is over 40.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every morning from preoperative day 3 up to postoperative day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every morning from preoperative day 3 up to postoperative day 7
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Nighttime wakefulness after persistent sleep onset (WASO)
Secondary study objectives
Total sleep time (TST)
Other study objectives
Delirium-free days
Duration of sleep during the day
Postoperative delirium
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: SuvorexantActive Control1 Intervention
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
861 Previous Clinical Trials
12,932,706 Total Patients Enrolled
11 Trials studying Delirium
3,009 Patients Enrolled for Delirium
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,680 Total Patients Enrolled
3 Trials studying Delirium
429 Patients Enrolled for Delirium
Matthias Eikermann, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
13 Previous Clinical Trials
175,381 Total Patients Enrolled
Matthias EikermannPrincipal Investigator - Montefiore Medical Center/Albert Einstein College of Medicine
Beth Israel Deaconess Medical Center, Harvard Medical Faculity Physicians @ Beth Israel Deaconess Medical CE, Massachusetts General Hospital
Balachundhar SubramaniamPrincipal InvestigatorBeths Israel Deaconess Medical Center
3 Previous Clinical Trials
335 Total Patients Enrolled