Recruiting

Observational Study

Sponsor:

Ceribell Inc.

Code:

NCT07449416

Conditions

Delirium in the Intensive Care Unit

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ceribell Delirium Monitoring System

Study Details

Brief summary:

This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.

Conditions

Delirium in the Intensive Care Unit

Study ID

NCT07449416

Start date

Mar 15, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Prospective Ceribell Delirium Monitoring

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.

no intervention: Retrospective Control

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.

Interventions

Ceribell Delirium Monitoring System

The Ceribell Delirium Monitor provides an assessment of delirium every 15 minutes during each EEG recording and provides a trend graph depicting the output of the algorithm. If delirium is detected, a CAM-ICU assessment will be performed to confirm the presence of delirium. The patient's care team will use the additional data provided by the Ceribell Delirium Monitor to inform decisions regarding alterations in the patient's delirium management.

Primary outcome measure

  • Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments [ Time Frame: From ICU admission to ICU discharge (up to 7 days) ]

Central Contacts and Locations

Central contacts

Michelle Hofmann, MSN

908-892-1193michelle.hofmann@ceribell.com

Alexandra C. Fietsam, PhD

563-209-1704courtney.fietsam@ceribell.com

Locations

University of California Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Masih Rafi, MD

949-824-7281mrafi@uci.edu

Principal Investigator:

Yama Akbari, MD, PhD

More Information

Sponsor

Ceribell Inc.

Last update posted

Jul 22, 2026

Last verified

Feb, 2026

Keywords

  • Delirium
  • Delirium Monitoring
  • Ceribell
  • Electroencephalogram (EEG)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ceribell Inc. on 2026-07-22.