Ceribell Delirium Data Collection Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Stanford, California, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroencephalogram (EEG) Test

Device

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

Other names: Delirium Assessments

Primary outcomes

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
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.

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Sponsors and collaborators

Lead sponsor

Ceribell Inc.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2026
First posted: Jul 15, 2021
Registry last updated: Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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