Ceribell Delirium Monitor Outcomes Pilot Study

NCT07449416 | Recruiting FDA Device

• 1 other identifier: 2025-01-P
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.

Conditions

Delirium in the Intensive Care Unit

Keywords

Delirium; Delirium Monitoring; Ceribell; Electroencephalogram (EEG)

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments

  Percentage of participants who receive at least one delirium diagnosis outside of routine morning and evening standard-of-care (SOC) assessments during the ICU stay.

  From ICU admission to ICU discharge (up to 7 days)

Secondary Outcomes (1)

• Changes in Delirium-Directed Management

  From ICU admission to ICU discharge (up to 7 days)

Study Arms (2)

Prospective Ceribell Delirium Monitoring

EXPERIMENTAL

ICU patients who meet the inclusion and exclusion criteria will be enrolled. These patients will undergo up to 12 hours of continuous EEG recording with the Ceribell Delirum Monitor for up to 7 days. If delirium is detected, the study staff will perform CAM-ICU assessments to determine the presence of delirium. Additionally, a Delirium Trend Report will be presented to each patient's care team during morning rounds and any alterations in patient care will be documented.

Device: Ceribell Delirium Monitoring System

Retrospective Control

NO INTERVENTION

Patients who met the inclusion and exclusion criteria during their ICU stay will be enrolled in the retrospective control arm. Study staff will collect data on delirium management and patient clinical outcomes from chart review.

Interventions

Ceribell Delirium Monitoring System DEVICE

The Ceribell Delirium Monitor provides an assessment of delirium every 15 minutes during each EEG recording and provides a trend graph depicting the output of the algorithm. If delirium is detected, a CAM-ICU assessment will be performed to confirm the presence of delirium. The patient's care team will use the additional data provided by the Ceribell Delirium Monitor to inform decisions regarding alterations in the patient's delirium management.

Prospective Ceribell Delirium Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is 18 years or older
• Admitted to the ICU for an expected duration ≥ 24 hours from enrollment
• Have at least one of the following conditions:
• Acute Sepsis or Septic Shock Admitted to the ICU following elective cardiothoracic surgery Acute respiratory failure requiring non-invasive ventilation or high-flow nasal cannula (HFNC) oxygenation Shock requiring vasopressor therapy Mechanically ventilated - Current RASS ≥ -3 and not expected to require deep sedation (RASS \< -3) during the ICU stay

You may not qualify if:

• \- 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.
• Baseline neurological dysfunction (Glasgow Coma Scale \< 10) and pre-existing brain injuries such as stroke with known deficits, severe TBI
• History of moderate-severe dementia (IQCODE ≥ 3.5)
• APACHE II score \> 30, or SOFA \> 9 at enrollment

Sponsors & Collaborators

• Ceribell Inc.: lead

Study Sites (2)

University of California Irvine

Irvine, California, 92697, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Michelle Hofmann, MSN

CONTACT

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

Alexandra C. Fietsam, PhD

CONTACT

563-209-1704; courtney.fietsam@ceribell.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot, multi-center, prospective, interventional, retrospective control

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)