Recruiting

Observational Study

Sponsor:

Ceribell Inc.

Code:

NCT04962815

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electroencephalogram (EEG) Test

Study Details

Brief summary:

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.

Conditions

Delirium

Study ID

NCT04962815

Start date

Nov 10, 2021

Status verified date

Jul, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Electroencephalogram (EEG) Test

EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.

Primary outcome measure

  • Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Michelle Hofmann, MSN

800-436-0826michelle.hofmann@ceribell.com

Jessy Dorn, PhD

800-436-0826jessy.dorn@ceribell.com

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Nicole Ann Toney

412-648-0608nat88@pitt.edu

Erik Yablonsky

412-648-0608ejy3@pitt.edu

Principal Investigator:

Timothy Girard, MD

More Information

Sponsor

Ceribell Inc.

Last update posted

Jul 25, 2025

Last verified

Jul, 2025

Keywords

  • delirium
  • EEG
  • Electroencephalogram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ceribell Inc. on 2025-07-25.