EEG Abnormalities in Adult ICU Patients With High Risk of Delirium

NCT07485244 | Recruiting FDA Device

• 1 other identifier: 2025-02-P
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the prevalence of EEG abnormalities on Ceribell POC EEG in adult medical, surgical, and cardiovascular ICU patients with high risk of delirium

Conditions

Delirium in the Intensive Care Unit

Keywords

Ceribell; Electroencephalogram (EEG); Delirium monitoring; Delirium

Outcome Measures

Primary Outcomes (1)

• Prevalence of EEG Abnormalities on the Ceribell EEG System

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

  Starting baseline through study completion, up to 1 year.

Study Arms (1)

Prospective Ceribell Delirium Monitoring

Enrolled patients will undergo EEG monitoring with the Ceribell EEG System twice daily for up to 7 days.

Device: Ceribell EEG System

Interventions

Ceribell EEG System DEVICE

EEG will be recorded with the Ceribell EEG System, including headband and recorder.

Prospective Ceribell Delirium Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients with high risk of delirium

You may qualify if:

• 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 \[e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)\].

You may not qualify if:

• 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

Sponsors & Collaborators

• Ceribell Inc.: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Michelle Hofmann, MSN

CONTACT

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

Alexandra C. Fietsam, PhD

CONTACT

5632091704; courtney.fietsam@ceribell.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 20, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)