Recruiting

EEG Abnormalities

Sponsor:

Ceribell Inc.

Code:

NCT07485244

Conditions

Delirium in the Intensive Care Unit

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ceribell EEG System

Study Details

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

Study ID

NCT07485244

Start date

Apr 16, 2026

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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.
  • 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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Prospective Ceribell Delirium Monitoring

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

Interventions

Ceribell EEG System

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

Primary outcome measure

  • Prevalence of EEG Abnormalities on the Ceribell EEG System [ Time Frame: Starting baseline through study completion, up to 1 year. ]

Central Contacts and Locations

Central contacts

Michelle Hofmann, MSN

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

Alexandra C. Fietsam, PhD

5632091704courtney.fietsam@ceribell.com

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Anya Harden

615-936-7355anya.e.harden@vumc.org

Principal Investigator:

Wesley Ely, MD, MPH

More Information

Sponsor

Ceribell Inc.

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Ceribell
  • Electroencephalogram (EEG)
  • Delirium monitoring
  • Delirium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ceribell Inc. on 2026-04-21.