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RecruitingNCT07485244Updated Apr 21, 2026

EEG Abnormalities in Adult ICU Patients With High Risk of Delirium

An observational study in Delirium in the Intensive Care Unit, sponsored by Ceribell Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Ceribell Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Delirium in the Intensive Care Unit

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Keywords

  • Ceribell
  • Electroencephalogram (EEG)
  • Delirium monitoring
  • Delirium
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult ICU patients with high risk of delirium

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceCeribell EEG System

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

05

What researchers measure

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

    Time frame: Starting baseline through study completion, up to 1 year.

06

Study locations

1 of 1 sites recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07485244
Lead sponsor
Ceribell Inc.
Collaborators
Vanderbilt University Medical Center
Responsible party
Sponsor
First posted
Mar 20, 2026
Start date
Apr 16, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Apr 21, 2026

Study contacts

Michelle Hofmann, MSN
Contact
michelle.hofmann@ceribell.com
908-892-1193
Alexandra C. Fietsam, PhD
Contact
courtney.fietsam@ceribell.com
5632091704

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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