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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first night after extubation between 11:00pm and 6:00am
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am scheduled for heart bypass or valve surgery and will be in the ICU afterwards.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nighttime wakefulness after persistent sleep onset (WASO)
Secondary outcome measures
Total sleep time (TST)
Other outcome measures
Delirium-free days
Duration of sleep during the day
Postoperative delirium
+2 moreTrial 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
837 Previous Clinical Trials
13,010,152 Total Patients Enrolled
9 Trials studying Delirium
2,533 Patients Enrolled for Delirium
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,551 Total Patients Enrolled
2 Trials studying Delirium
333 Patients Enrolled for Delirium
Matthias Eikermann, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
13 Previous Clinical Trials
175,381 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients are being enrolled in this trial?
"Yes, according to the information on clinicaltrials.gov, this study is currently recruiting patients. The trial was first posted on February 28th 2020 and was last updated on May 18th 2022. The study is looking for 120 participants at 2 locations."
Answered by AI
When was the FDA's most recent decision on Suvorexant?
"Suvorexant has completed Phase 4 clinical trials, and thus it is considered safe enough for public consumption."
Answered by AI
Are there any unfilled positions in this clinical trial for testing new treatments?
"Currently, this clinical trial is seeking patients that match its eligibility criteria. The first posting was on February 28th 2020 with the most recent update being from May 18th 2022."
Answered by AI
Can you name a few more studies that have been done on Suvorexant?
"Suvorexant was first studied in 2019 at Montana State University. So far, there are 88 completed trials with 14 more currently underway. Of these live clinical trials, many are based in Boston, Massachusetts."
Answered by AI
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