Ceribell Delirium Monitor Outcomes Pilot Study

Part of paid clinical trials in Irvine, California.

Sponsor
Ceribell Inc.
Study ID
NCT07449416
Status
Recruiting
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Conditions

  • Delirium in the Intensive Care Unit

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

First listed
Mar 4, 2026
Start date
Mar 15, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Prospective Ceribell Delirium Monitoring
    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.
  • No Intervention: Retrospective Control
    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.

Primary Outcome Measure

Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments [ Time Frame: From ICU admission to ICU discharge (up to 7 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California IrvineIrvineCalifornia92697
Masih Rafi, MD
[email protected]
949-824-7281
Yama Akbari, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15261
Tina Vita
[email protected]
(412) 864-9191
Timothy Girard, MD, MSCI (PRINCIPAL_INVESTIGATOR)

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