Ceribell Delirium Monitor Outcomes Pilot Study
Ceribell Inc. · NCT07449416
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- March 15, 2026
- Record last updated
- July 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.
Being studied: Ceribell Delirium Monitoring System
Conditions: Delirium in the Intensive Care Unit
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
University of California Irvine
Irvine, CA 92697
Site contact: Masih Rafi, MD · 949-824-7281 · mrafi@uci.edu
Study contacts (from the official record)
- Michelle Hofmann, MSN · 908-892-1193 · michelle.hofmann@ceribell.com
- Alexandra C. Fietsam, PhD · 563-209-1704 · courtney.fietsam@ceribell.com