Early Delirium Prediction Via Serial EEG Trajectories and Machine Learning

April 12, 2026 updated by: Jinjoo Kim, Ajou University School of Medicine

Longitudinal Frontal EEG Trajectories Reveal Divergent Cortical Dynamics in Delirium After Severe Trauma

The goal of this observational study is to develop a machine learning model that can predict delirium in trauma patients before it clinically appears. The study focuses on analyzing brainwave (EEG) patterns collected over several days in the trauma ICU. By comparing different recording conditions-such as having eyes open versus closed-researchers aim to identify the most effective way to monitor brain health and detect early signs of delirium in critically ill patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Background and Rationale:

Delirium is a critical manifestation of acute brain dysfunction, affecting 10-15% of all hospitalized patients and over 25% of those in intensive care units (ICU). In the trauma ICU, patients are particularly vulnerable due to an inflammatory cascade from repeated surgeries, blood-brain barrier disruption, traumatic brain injury (TBI), and mandatory opioid administration. Despite its clinical significance-including increased mortality and long-term cognitive impairment-early detection remains challenging. Current bedside tools like the CAM-ICU are limited by their periodic nature and dependence on clinician expertise, often missing the rapid neurophysiologic fluctuations that define delirium.

Study Objectives and Methodology:

While previous studies have used electroencephalography (EEG) as a "snapshot" to identify delirium, such cross-sectional approaches often reflect transient sedative depth rather than true neurocognitive vulnerability. This study proposes a longitudinal approach, focusing on the trajectory of change in cortical dynamics over time.

We acquired brief, serial resting-state EEG three times daily for at least three consecutive days from critically ill trauma patients. Using a feasible frontal montage, we quantified a comprehensive set of features, including spectral power (slowing), nonlinear complexity, and phase-based functional connectivity.

Research Hypothesis:

The framework utilizes machine learning (ML) to harness these longitudinal trajectories, aiming to predict delirium vulnerability before formal clinical diagnosis. Furthermore, we hypothesize that eyes-open recordings-by imposing a minimal arousal constraint-will better capture wakeful network integrity and provide superior predictive power compared to traditional eyes-closed recordings, which are often confounded by sedation and drowsiness in the trauma ICU environment.

Clinical Impact:

By identifying the optimal recording condition and establishing an ML-based prediction framework, this study seeks to define a standardized neurophysiologic monitoring strategy. This will ultimately facilitate early intervention and improve the long-term neurological prognosis of severe trauma survivors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Contacts and Locations

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

Study Locations

  • South Korea
    • Kyonggi-do
      • Suwon, Kyonggi-do, South Korea, 16499
        • Ajou University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult trauma patients (aged 18-65) admitted to the Trauma Intensive Care Unit (TICU) at a level 1 trauma center in Korea. The cohort includes critically ill patients with a record of severe injury (ISS≥ 9) who are able to undergo serial EEG monitoring and clinical delirium assessments. Patients with pre-existing neurological or psychiatric disorders, or those with severe traumatic brain injury (AIS ≥ 2), are excluded to ensure the specificity of the neurophysiologic data.

Description

  1. Inclusion Criteria:

    Trauma patients admitted to the Trauma Intensive Care Unit (TICU) who meet the following criteria:

    • Patients aged 18 to 65 years.
    • Severe trauma patients with an Injury Severity Score (ISS)
  2. Exclusion Criteria:

Patients with a head Abbreviated Injury Scale (AIS) ≥ 2 Patients with a Richmond Agitation-Sedation Scale (RASS) score ≤ -2 History of neurological disorders (e.g., Parkinson's disease, dementia, cerebrovascular disease) History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, intellectual disability, autism spectrum disorder) History of illicit drug use disorder or positive results on a urine drug screen for substances other than Benzodiazepines or Tricyclic antidepressants.

Clinical evidence of acute alcohol withdrawal (CIWA-Ar score > 10) History of liver failure or hepatic encephalopathy (Child-Pugh Class B or C) Renal impairment requiring renal replacement therapy (RRT) Inability to perform the Confusion Assessment Method for the ICU (CAM-ICU) due to the following Inability to communicate in Korean Failure to obey commands (unable to follow test instructions) Severe visual or hearing impairment Refusal to undergo CAM-ICU assessment Requirement for isolation due to infectious diseases (e.g., COVID-19, active tuberculosis).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Delirum group
Patients who developed delirium during their ICU stay (confirmed by CAM-ICU)
Non-Delirium Group
Patients who did not develop delirium during their ICU stay.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Predictive Performance for Delirium (Area Under the Receiver Operating Characteristic Curve, AUROC
Time Frame: 3 to 4 days (during the longitudinal EEG data collection period)
The predictive accuracy of the machine learning model based on longitudinal EEG trajectories will be evaluated to identify patients at risk of delirium. Model performance will be assessed using AUROC, sensitivity, specificity, and F1-score.
3 to 4 days (during the longitudinal EEG data collection period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of Model Performance: Eyes-Open vs. Eyes-Closed States
Time Frame: 3 to 4 days
Comparison of the area under the receiver operating characteristic curve (AUROC) between EEG data recorded during eyes-open and eyes-closed resting states to determine which condition provides superior predictive power.
3 to 4 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ajou University School of Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AJOUIRB-IV-2024-227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional policies regarding data privacy and the protection of sensitive patient information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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