Actively Recruiting
EEG Abnormalities in Adult ICU Patients With High Risk of Delirium
Led by Ceribell Inc. · Updated on 2026-04-21
100
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Ceribell Inc.
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the occurrence of EEG abnormalities in adult patients at high risk of delirium who are admitted to medical, surgical, and cardiovascular intensive care units (ICUs). The study aims to better understand the prevalence of these EEG changes using a point-of-care EEG device called the Ceribell EEG System. This observational study is sponsored by Ceribell Inc. and focuses on adults aged 18 and older. Participants will be monitored using the Ceribell EEG System, which includes a headband and recorder, to record EEG twice daily for up to seven days. This device is used to assess brain activity and detect abnormalities that may be linked to delirium in ICU patients. The study does not involve treatment interventions but focuses on observation and data collection. During the study, participants will undergo EEG monitoring while receiving usual ICU care. Researchers will track the presence of EEG abnormalities from baseline through up to one year after enrollment. The study also includes gathering clinical information to assess delirium risk and brain function. Participation involves no additional treatment but requires consent and adherence to monitoring schedules.
CONDITIONS
Brief Title
EEG Abnormalities in Adult ICU Patients With High Risk of Delirium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient 18 years old or older
- Admitted to a medical, surgical, or cardiovascular ICU with an expected stay of 24 hours or more
- Receiving treatment for shock or respiratory failure such as mechanical ventilation or non-invasive positive pressure ventilation
You will not qualify if you...
- Structural head abnormality or device preventing use of the Ceribell EEG system during monitoring
- Use of continuous EEG for reasons other than delirium detection during monitoring
- Mechanical ventilation for more than 72 hours during current hospitalization or long-term ventilator use before current injury
- Expected death within 12 hours or lack of treatment commitment
- Neurologic deficits preventing delirium assessment
- Inability to understand English
- Bilateral deafness
- Blindness preventing delirium evaluation
- Enrollment in conflicting studies
- Inability to provide informed consent
- Physician refusal
- Patient or surrogate refusal
- No surrogate available if patient unable to consent
- Prisoner status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants undergo EEG monitoring with the Ceribell EEG System twice daily.
Twice daily monitoring visits for up to 7 days
Duration - Up to 1 year
Participants are observed for EEG abnormalities from baseline through study completion.
Visit frequency varies; observation continues up to 1 year
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
M
Michelle Hofmann, MSN
A
Alexandra C. Fietsam, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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