Stanford-Lucidify EEG Delirium Study

NCT06999967 | Not Yet Recruiting

• 1 other identifier: 81015
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of the CGX/Lucidify EEG system in enabling physicians to detect delirium (confusion) in medically ill patients as early as possible in order to minimize the detrimental effects of delirium. The study will involve collecting EEG data through the CGX EEG system (a Research-grade 2-Channel EEG device) and applying the Lucidify EEG software algorithm to identify indicators and degree of delirium, obtain data regarding the amount and degree of patient's movement and activity throughout the day in order to detail delirium subtype, and obtain data regarding the quality of the sleep as it affects delirium severity and duration. By enhancing early detection, this research aims to improve patient outcomes and inform clinical decision-making.

Conditions

Delirium; Cognitive Dysfunction

Keywords

Delirium; EEG; Encephalopathy; Cognitive Dysfunction; Electroencephalography; Delirium Monitoring

Outcome Measures

Primary Outcomes (3)

• Number of subjects with delirium accurately diagnosed by the CGX EEG/Lucidify System

  Record and collect EEG brain waves on study subjects using the CGX EEG/Lucidify System to assess EEG features to differentiate between delirium positive and delirium negative patients.

  24-hours a day monitoring for a minimum of 3 days from enrollment to the end of the study period (maximum of 7 days post-enrollment)

• Development of Delirium

  Number of subjects diagnosed with delirium

  From enrollment to the end of the study period (maximum of 7 days post-enrollment)

• Determination of Delirium Phenotype

  For those who develop delirium, the phenotype of delirium will be determined as per the Liptzin-Levkoff Criteria (based on DSM diagnostic Criteria). As such, all delirium episodes will be categorized as: hyperactive, hypoactive, mixed, or subsyndromal delirium. In addition, this phenotype determination will be compared with the CGX/Lucidify EEG System accelerometer data to determine concordance between the two.

  From enrollment to the end of the study period (maximum of 7 days post-enrollment)

Secondary Outcomes (10)

• Immediate Post-hospital Admission Mortality

  From date of admission up to time of discharge (assessed up to 1 year after admission)

• Length of ICU & Hospital Stay

  From date of admission up to time of discharge of the ICU or oncology ward, and then from the hospital (assessed up to 1 year after admission)

• Polysomnography Sleep Metrics - Stages of Sleep

  24 hours a day for a maximum of 7 days

• Polysomnography Sleep Metrics - Depth of sleep

  24 hours a day for a maximum of 7 days

• Polysomnography Sleep Metrics - Duration of Sleep

  24 hours a day for a maximum of 7 days

Study Arms (2)

ICU Population

Subjects admitted to the Intensive Care Unit (ICU)

Diagnostic Test: Electroencephalogram (EEG)

Oncology Population

Subjects admitted to oncology units with hematologic malignancies undergoing cellular therapies or hematopoietic stem cell transplants (e.g., stem cell and Chimeric Antigen Receptor T-cell (CAR-T) Therapy)

Diagnostic Test: Electroencephalogram (EEG)

Interventions

Electroencephalogram (EEG) DIAGNOSTIC_TEST

All study subjects will undergo monitoring via a portable electroencephalogram (pEEG), the CGX EEG system (a Research-grade 2-Channel EEG device) to measure the brainwaves of patients admitted to Stanford Medical Center. Investigators will then use the Lucidify software to allow for the interpretation of obtained brainwaves for the detection of delirium .

ICU Population; Oncology Population

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects admitted to the ICU or Oncology hospital wards

You may qualify if:

• Age is 55 years or older
• Clinical suspicion of delirium or subject at risk for delirium
• Admitted to the Intensive Care Unit (ICU) or Oncology wards
• Expected hospital stay is greater than one (1) day
• Subject must be fluent in English

You may not qualify if:

• Age is younger than 55 years
• Subjects with a primary neurological or neurosurgical condition such as stroke, epilepsy, brain tumor, or witnessed seizures, Parkinson's disease, traumatic brain injury, or s/p craniectomy
• Active CNS substance abuse, intoxication, or withdrawal
• Unarousable or unresponsive subjects with RASS \<-3
• Subject is blind, deaf, or unable to speak or understand English

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Brain Diseases

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• José R Maldonado, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek O Pipolo, M.D.

CONTACT

949-945-4992; dpipolo@stanford.edu

Dina Ganji, M.D.

CONTACT

925-558-6733; dganji@stanford.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Psychiatry Laboratory Director

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 31, 2025
• Study Start: June 1, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)