Ceribell Delirium Monitor Outcomes Pilot Study
Key facts
- Who runs it
- Ceribell Inc.
- Where
- Irvine and Pittsburgh, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 15 Mar 2026
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Ceribell Delirium Monitoring System
- Record updated
- 22 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
- University of California, IrvineIrvine, United StatesContact: Masih Rafi, MDTaking people
- University of Pittsburgh Medical CenterPittsburgh, United StatesContact: Tina VitaNot yet recruiting
About the trial
What the trial wants to find out
This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.
The 2 groups in the trial
- Prospective Ceribell Delirium MonitoringTreatment being tested
ICU patients who meet the inclusion and exclusion criteria will be enrolled. These patients will undergo up to 12 hours of continuous EEG recording with the Ceribell Delirum Monitor for up to 7 days. If delirium is detected, the study staff will perform CAM-ICU assessments to determine the presence of delirium. Additionally, a Delirium Trend Report will be presented to each patient's care team during morning rounds and any alterations in patient care will be documented.
Treatment: Ceribell Delirium Monitoring System
- Retrospective ControlNo study treatment, for comparison
Patients who met the inclusion and exclusion criteria during their ICU stay will be enrolled in the retrospective control arm. Study staff will collect data on delirium management and patient clinical outcomes from chart review.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 22 July 2026