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Observational Study of EEG Abnormalities in ICU Patients at High Risk for Delirium

This study is looking at adults (18 years or older) who are in the intensive care unit (ICU) for at least 24 hours and are at high risk for delirium. Delirium is a serious change in mental abilities, often seen in very sick patients. Researchers will use the Ceribell EEG System, which includes a headband and recorder, to measure brain activity (EEG). The main goal is to see how many of these patients have abnormal brain activity patterns. This is an observational study, meaning researchers will collect information without giving any specific treatments. The current status of the study is unclear, and it plans to include 100 participants.

Study design
This is an observational study that plans to enroll 100 adult participants. It is not a randomized or blinded study.
What's involved
Your brain activity will be recorded using the Ceribell EEG System, which involves wearing a headband and recorder. This recording will happen from the start of the study until it's completed, up to one year.
Compensation
Not stated in the trial record.
Follow-up
Your brain activity will be monitored from the beginning of the study through its completion, which could be up to one year.

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NCT07485244

EEG Abnormalities in Adult ICU Patients With High Risk of Delirium

Recruiting
Not specifiedAges 18+Observational
Ceribell Inc.
~100 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Ceribell EEG System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of EEG Abnormalities on the Ceribell EEG System
Measured over Starting baseline through study completion, up to 1 year.

Conditions

Delirium in the Intensive Care Unit

Explore related trials

Delirium

Where it's being run

1 sites across 1 states
Tennessee1

Who to contact

Michelle Hofmann, MSN
[email protected]
908-892-1193
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult patient ≥18 years old
Requiring admission to a medical, surgical and/or cardiovascular ICU for an expected duration ≥ 24 hours
Receiving treatment for shock (e.g., with vasopressors, intra-aortic balloon pump, or Extracorporeal Membrane Oxygenation therapy) and/or respiratory failure \[e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)\].

Exclusion

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.
Patients who have been on mechanical ventilation for \>72 hours within the current hospitalization or who are on long-term ventilator support prior to the injury that resulted in the current hospitalization.
Expected death within 12 hours of enrollment or lack of commitment to treatment by family or the medical team (e.g., likely to withdraw life support measures within 12 hours of enrollment).
Acute or chronic neurologic deficit precluding CAM-ICU assessments
Inability to understand English
Bilateral Deafness
Blindness that will preclude delirium evaluation
Current enrollment in a study that does not allow co-enrollment
Inability to obtain informed consent
Attending physician refusal
Patient and/or surrogate refusal
Patient unable to consent and no surrogate available
Prisoners

What this trial measures

  • Prevalence of EEG Abnormalities on the Ceribell EEG SystemStarting baseline through study completion, up to 1 year.

    Prevalence of EEG abnormalities, including epileptiform and ictal-interictal continuum (IIC) patterns, recorded on the Ceribell EEG System