Ceribell Delirium Monitor Outcomes Pilot Study (DOM)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium in the Intensive Care Unit
• Intervention / Treatment: Device: Ceribell Delirium Monitoring System

Detailed Description

The purpose of this non-powered pilot study is to assess the feasibility of adding the Ceribell Delirium Monitor to the standard of care delirium assessment and management workflow, identify potential differences in patient outcomes between the control and intervention cohorts, and inform the design of a future randomized controlled trial.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Hofmann, MSN; Phone Number: 908-892-1193; Email: michelle.hofmann@ceribell.com
• Study Contact Backup: Name: Alexandra C. Fietsam, PhD; Phone Number: 563-209-1704; Email: courtney.fietsam@ceribell.com

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine
      • Contact: Masih Rafi, MD; Phone Number: 949-824-7281; Email: mrafi@uci.edu
      • Principal Investigator: Yama Akbari, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments	Percentage of participants who receive at least one delirium diagnosis outside of routine morning and evening standard-of-care (SOC) assessments during the ICU stay.	From ICU admission to ICU discharge (up to 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Delirium-Directed Management	Documented changes in pharmacologic or non-pharmacologic delirium-directed treatment or management per participant during the ICU stay. A change is defined as initiation, discontinuation, or dose adjustment of a delirium-directed medication, or implementation of a new non-pharmacologic delirium intervention.	From ICU admission to ICU discharge (up to 7 days)

Collaborators and Investigators

• Sponsor: Ceribell Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Delirium; Electroencephalogram (EEG); Delirium Monitoring; Ceribell
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium
• Other Study ID Numbers: 2025-01-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No