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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 below

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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:

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My cognitive test score was below 23.

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I use a CPAP machine for severe sleep apnea.

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I do not have severe kidney problems or need dialysis.

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I am currently experiencing confusion and restlessness.

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I am not in a coma.

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My liver is functioning well (CHILD-Pugh ≤ 4).

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every morning from preoperative day 3 up to postoperative day 7 for reporting.