Ceribell Monitoring for Delirium
(DOM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new system called the Ceribell Delirium Monitoring System to determine its effectiveness in detecting delirium in ICU patients. Delirium is a serious confusion and mental state that can occur suddenly in critically ill individuals. In this study, some patients will have their brain activity monitored continuously to assess whether this system can better identify and help manage delirium. Suitable candidates for this trial include those admitted to the ICU with serious conditions like sepsis or respiratory failure. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance delirium detection and management in critical care settings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Ceribell Delirium Monitoring System is safe for ICU patients?
Research has shown that the Ceribell Delirium Monitoring System is safe for use. The FDA has approved it, confirming it meets safety standards. Studies demonstrate its effectiveness in detecting delirium, a state of confusion, by monitoring brain waves. Specifically, research involving 225 patients confirmed the system's accurate detection of delirium. These findings indicate that the Ceribell system is generally well-tolerated, with no major side effects reported.12345
Why are researchers excited about this trial?
Researchers are excited about the Ceribell Delirium Monitoring System because it offers a new way to detect and manage delirium in ICU patients. Unlike current methods that rely on sporadic assessments, this system uses continuous EEG monitoring, providing real-time data to identify delirium more quickly and accurately. This continuous monitoring allows healthcare teams to receive Delirium Trend Reports, which can lead to more informed and timely decisions during patient care. The hope is that the system will catch delirium earlier than traditional methods, potentially improving patient outcomes and reducing the duration of ICU stays.
What evidence suggests that the Ceribell Delirium Monitoring System is effective for monitoring delirium?
Research has shown that the Ceribell Delirium Monitoring System effectively detects delirium in ICU patients. In this trial, participants in the prospective Ceribell Delirium Monitoring arm will undergo continuous EEG monitoring with the Ceribell system. This system uses EEG, a test that measures brain activity, to identify delirium more quickly than traditional bedside checks. Studies have found that using Ceribell can improve neurological outcomes by 18% and reduce ICU stays by 4.1 days. The FDA has cleared the system, indicating it has been reviewed and approved for safety and effectiveness. Overall, these findings suggest that Ceribell can enhance the detection and management of delirium in critically ill patients.12356
Are You a Good Fit for This Trial?
This trial is for adults (18+) in the ICU with severe infections, breathing problems needing special oxygen support or a ventilator, or shock needing medication. Participants must be alert enough and expected to stay in the ICU at least 24 hours.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prospective Ceribell Delirium Monitoring
ICU patients undergo up to 12 hours of continuous EEG recording with the Ceribell Delirium Monitor for up to 7 days. Delirium Trend Reports are presented during morning rounds.
Retrospective Control
Data on delirium management and patient clinical outcomes are collected from chart review for patients in the retrospective control arm.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ceribell Delirium Monitoring System
Trial Overview
The study tests the Ceribell Delirium Monitoring System to see if it helps detect delirium in ICU patients. It compares outcomes before and after using this monitoring device.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ceribell Inc.
Lead Sponsor
Citations
NCT04962815 | Ceribell Delirium Data Collection Study
The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the ...
2.
investors.ceribell.com
investors.ceribell.com/news-releases/news-release-details/ceribell-receives-fda-510k-clearance-first-its-kind-delirium/Ceribell Receives FDA 510(k) Clearance for First-of-its- ...
Ceribell offers a reliable continuous monitoring solution that has the potential to improve delirium detection rates and management, and reduce ...
Ceribell Monitoring for Delirium (DOM Trial)
Ceribell Delirium Monitoring System ... Study staff will collect data on delirium management and patient clinical outcomes from chart review.
Current Gaps in Delirium Recognition and Management
A majority (63-90%) perceived that current bedside assessments delay and limit the recognition of ICU delirium. Nearly all (89%) agreed an ...
December 8, 2025 Ceribell, Inc. Raymond Woo CTO 360 N ...
The safety and effectiveness of the Delirium Monitor System to perform a delirium assessment was supported by clinical performance data. The ...
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