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Ceribell Delirium Monitor Pilot Study for ICU Patients

This study is testing a device called the Ceribell Delirium Monitoring System in patients admitted to the Intensive Care Unit (ICU) who are experiencing delirium. The Ceribell monitor assesses for delirium every 15 minutes during an EEG (electroencephalogram, a test that measures brain activity) recording. If delirium is detected, a CAM-ICU (Confusion Assessment Method for the ICU) assessment will be done to confirm it. The main goal is to see how many people are diagnosed with delirium using this monitor, compared to standard care. You might be able to join if you are 18 or older, expected to be in the ICU for at least 24 hours, and have certain conditions like sepsis or acute respiratory failure. The current recruitment status is unclear.

Study design
This is a pilot study comparing a group of patients using the Ceribell Delirium Monitor to a group of past patients. It aims to enroll 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from ICU admission until ICU discharge, for up to 7 days.

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NCT07449416

Ceribell Delirium Monitor Outcomes Pilot Study

Recruiting
NAAges 18+InterventionalScreening
Ceribell Inc.
~100 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Ceribell Delirium Monitoring System

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments
Measured over From ICU admission to ICU discharge (up to 7 days)

Conditions

Delirium in the Intensive Care Unit

Explore related trials

Delirium

Where it's being run

2 sites across 2 states
California1
Pennsylvania1

Who to contact

Michelle Hofmann, MSN
[email protected]
908-892-1193
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Eligibility criteria

Inclusion

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:

Exclusion

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

What this trial measures

  • Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care AssessmentsFrom ICU admission to ICU discharge (up to 7 days)

    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.