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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: Completed Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
NCT04092894 is a Phase 4 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Nighttime wakefulness after persistent sleep onset (WASO) will be measured using a SedLine® Brain Function Monitor. WASO will be defined as the duration of wakefulness after the onset of persistent sleep in the observation period between 11:00pm (Lights-Off) to 6:00am (Lights-On) in minutes. Onset of persistent sleep will be defined as the first epoch of 10 consecutive minutes of sleep (REM or non-REM Stages 1, 2, 3 or 4) after Lights-Off. Wakefulness will be defined as any epoch of Stage 0. Sle
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 |
What the finished NCT04092894 record still lists
NCT04092894 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04092894 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04092894's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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