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NCT04092894 · ClinicalTrials.gov registry record · Phase 4
Suvorexant and Sleep/Delirium in ICU Patients
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT04092894 is a Phase 4 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 100 participants.
The verdict
NCT04092894, a Phase 4 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo oral tablet
- DRUG Suvorexant 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-02-28 |
| Est. Completion | 2025-07-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04092894
The ClinicalTrials.gov registry entry for NCT04092894 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04092894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04092894 about?
NCT04092894 is a clinical study titled "Suvorexant and Sleep/Delirium in ICU Patients". 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 ar...
What is the current status of trial NCT04092894?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2020-02-28. Estimated completion is 2025-07-01.
What interventions are being tested in trial NCT04092894?
The interventions under investigation include: Placebo oral tablet (DRUG), Suvorexant 20 mg (DRUG).
Who is sponsoring clinical trial NCT04092894?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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