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Suvorexant and Sleep/Delirium in ICU Patients

NCT04092894 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-27

Study results available
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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.

Conditions

  • Insomnia
  • Sleep Fragmentation
  • Sleep Initiation and Maintenance Disorders
  • Postoperative Delirium

Interventions

DRUG

Suvorexant 20 mg

Administration of oral Suvorexant 20 mg

DRUG

Placebo oral tablet

Administration of oral placebo (same non-identifiable form as active comparator)

Sponsors & Collaborators

Principal Investigators

  • Matthias Eikermann · Montefiore Medical Center/Albert Einstein College of Medicine

  • Balachundhar Subramaniam · Beths Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2025-02-26
Completion
2025-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092894 on ClinicalTrials.gov