Stanford-Lucidify EEG Delirium Study

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06999967
Status
Not Yet Recruiting

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Conditions

  • Cognitive Dysfunction
  • Delirium

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

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 .

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Sep 30, 2025
Completion
May 30, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: ICU Population
    Subjects admitted to the Intensive Care Unit (ICU)
  • Arm: 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)

Primary Outcome Measure

Number of subjects with delirium accurately diagnosed by the CGX EEG/Lucidify System [ Time Frame: 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Hospital and ClinicsStanfordCalifornia94305
Derek O Pipolo, M.D.
[email protected]
949-945-4992
Dina Ganji, M.D.
[email protected]
925-558-6733
José R Maldonado, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford Hospital and Clinics· Stanford, CA

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