Ceribell Delirium Monitor Pilot in ICU Patients
Official title: Ceribell Delirium Monitor Outcomes Pilot Study
Run by Ceribell Inc. · NCT07449416 · Data updated 2026-11-12
This pilot test uses the Ceribell Delirium Monitor in ICU patients to see if adding EEG-based delirium monitoring is feasible and how it might affect outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ceribell Inc. Industry-sponsored |
| Locations | 2 sites (Irvine, California and 1 other locations) |
| Status | Recruiting |
| Started | March 15, 2026 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07449416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) in the ICU with an expected stay ≥24 hours who have acute sepsis/septic shock, recent elective cardiothoracic surgery, acute respiratory failure requiring advanced oxygen therapy, shock needing vasopressors, or mechanical ventilation with certain arousal criteria.
✕Probably not a fit
Patients who cannot undergo Ceribell EEG monitoring due to cranial or structural head conditions or who require EEG for purposes other than delirium during the monitoring period.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This non-powered pilot study will compare a prospective intervention cohort using Ceribell Delirium Monitoring with a retrospective control cohort receiving standard delirium care. The goal is to determine feasibility of integrating Ceribell EEG monitoring into the ICU workflow and to identify potential differences in patient outcomes to inform a future randomized design. The study collects data on delirium assessment and management alongside usual care. It is conducted in adults in the ICU who meet specific medical criteria and are expected to stay for at least 24 hours. The investigation seeks to clarify whether EEG-based monitoring can be practically implemented and whether it may influence care decisions.
Why it matters
Potential benefit: If successful, the trial could support more widespread use of EEG-based delirium monitoring to improve detection and management.
How similar studies have gone: Previous work in delirium monitoring with EEG tools has shown feasibility in ICU settings; this pilot aims to build on that with a specific Ceribell system.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age is 18 years or older * Admitted to the ICU for an expected duration ≥ 24 hours from enrollment * Have at least one of the following conditions: Acute Sepsis or Septic Shock Admitted to the ICU following elective cardiothoracic surgery Acute respiratory failure requiring non-invasive ventilation or high-flow nasal cannula (HFNC) oxygenation Shock requiring vasopressor therapy Mechanically ventilated - Current RASS ≥ -3 and not expected to require deep sedation (RASS \< -3) during the ICU stay Exclusion Criteria: \- Any structural abnormality or head condition, including the presence of a device, that would prevent the use of the Ceribell EEG system for the entire anticipated EEG monitoring period. Examples include: Craniectomy with a missing bone flap in a region where Ceribell EEG electrodes would be placed. Anticipated use of continuous EEG for a purpose other than delirium detection during the entire expected monitoring period. * Baseline neurological dysfunction (Glasgow Coma Scale \< 10) and pre-existing brain injuries such as stroke with known deficits, severe TBI * History of moderate-severe dementia (IQCODE ≥ 3.5) * APACHE II score \> 30, or SOFA \> 9 at enrollment
Where it's running
-
University of California Irvine
Irvine, California, United States Recruiting -
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Not yet recruiting
Study contacts
- Study coordinator: Michelle Hofmann, MSN
- Email: michelle.hofmann@ceribell.com
- Phone: 908-892-1193
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.