Delirium in the Intensive Care UnitNCT07485244
EEG Abnormalities in Adult ICU Patients With High Risk of Delirium
An observational study of Delirium in the Intensive Care Unit, run by Ceribell Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium in the Intensive Care Unit
- What is being tested?
- Ceribell EEG System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients with high risk of delirium
Who may be able to join
- 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)].
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Anya Harden, 615-936-7355, anya.e.harden@vumc.org
Wesley Ely, MD, MPH
About this study
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
- Being tested
- Ceribell EEG System
- Keywords
- Ceribell, Electroencephalogram (EEG), Delirium monitoring, Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceribell EEG SystemDevice
EEG will be recorded with the Ceribell EEG System, including headband and recorder.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Ceribell Delirium Monitoring | Enrolled patients will undergo EEG monitoring with the Ceribell EEG System twice daily for up to 7 days. Receives: Device: Ceribell EEG System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Starting baseline through study completion, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start16 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in the Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceribell Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485244
- Sponsor's protocol ID
- 2025-02-P
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Abnormalities in Adult ICU Patients With High Risk of Delirium
- ClinicalTrials.gov ID
- NCT07485244
- Acronym / sponsor ID
- 2025-02-P
- Conditions
- Delirium in the Intensive Care Unit
- Keywords
- Ceribell, Electroencephalogram (EEG), Delirium monitoring, Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ceribell Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Ceribell Delirium Monitoring | – | Device: Ceribell EEG SystemEnrolled patients will undergo EEG monitoring with the Ceribell EEG System twice daily for up to 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients with high risk of delirium
Key inclusion criteria (3 listed)
- 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)].
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceribell EEG SystemEEG will be recorded with the Ceribell EEG System, including headband and recorder. | Device | Prospective Ceribell Delirium Monitoring |
Primary outcome
Prevalence of EEG Abnormalities on the Ceribell EEG System
Time frame: Starting 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium in the Intensive Care Unit, run by Ceribell Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Hofmann, MSN (908-892-1193, michelle.hofmann@ceribell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of EEG Abnormalities on the Ceribell EEG System (time frame: Starting baseline through study completion, up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.