Ceribell Delirium Data Collection Study

July 22, 2025 updated by: Ceribell Inc.
This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the development of future software algorithms to assess the presence and severity of delirium.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Active, not recruiting
        • Stanford University
    • Florida
      • Naples, Florida, United States, 34102
        • Active, not recruiting
        • Naples Community Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Active, not recruiting
        • University of Iowa Hospitals & Clinics
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Active, not recruiting
        • Mercy
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Active, not recruiting
        • Cooper Health
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Active, not recruiting
        • UNC Health Rex
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy Girard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects who experience at least one delirious episode during their ICU stay

Description

Inclusion Criteria: All must be present

  • Age is 18 years or older
  • Admitted to the Intensive Care Unit (ICU)
  • Subject must be fluent in the language in which the delirium assessment is performed

Exclusion Criteria: All must be absent

- Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment
Time Frame: 3 times per day, for a maximum of six (6) days
Research coordinator will perform and collect CAM-ICU assessment data on study subjects
3 times per day, for a maximum of six (6) days
Perform Electroencephalogram (EEG) Test
Time Frame: 6-8 hours per day, for a maximum of six (6) days
Record and collect EEG brain waves on study subjects using Ceribell Rapid Response EEG to assess multiple time-frequency EEG features to differentiate between delirium positive and delirium negative patients.
6-8 hours per day, for a maximum of six (6) days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceribell Inc.

Investigators

  • Principal Investigator: Jose Maldonado, MD, Stanford University
  • Principal Investigator: Timothy Girard, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Site investigators will have access to the participant EEG data via Ceribell EEG portal. In addition, site investigators will have access to delirium assessments conducted for study purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: This website is password protected and the de-identified individual participant data is only available to participating research sites.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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