ClinicalTrials.gg
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

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
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

In context

Delirium

933 studies on the registry are indexed under Delirium; 190 are open to participants now.

This study's planned enrollment of 100 is below the median of 194 across 342 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Ceribell Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Attending physician refusal
  • Patient and/or surrogate refusal
  • Patient unable to consent and no surrogate available
  • Prisoners
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.

Of 178 observational studies under Delirium, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2026
First posted
Mar 20, 2026
StartActual
Apr 16, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Sep 30, 2027
Last update
Apr 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07485244
Lead sponsor
Ceribell Inc.
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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