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Development of an Innovative Delirium Prediction and Prevention Approach Utilizing AI Monitors, Simplified EEG, and Actigraphy

Development of a Novel Delirium Prediction Algorithm and Preventive Intervention Using Multimodal AI Monitors, Simplified EEG, and Actigraphy - AIDE-P Project

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061931
Enrollment
36
Registered
2026-06-16
Start date
2026-06-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delirium

Interventions

For patients scheduled for major cardiovascular surgery and ICU admission who provided informed consent, the following sequential interventions and evaluations will be performed: 1. [Screening] Pre
patients scoring 24 or higher will be enrolled. 2. [Preoperative Evaluation] On the morning after admission, a research-specific blood sample (approx. 70 mL) will be collected, and DRS-R98 and MMSE a

Sponsors

Saga University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients scheduled to undergo elective cardiovascular surgery at our hospital with confirmed subsequent admission to the Intensive Care Unit (ICU). Patients aged 70 years or older and under 80 years at the time of obtaining informed consent. Patients (or their legally authorized representatives) who provided written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: Patients aged under 70 years or 80 years and older. Patients with cognitive decline, including dementia, defined as a Mini-Mental State Examination (MMSE) score of less than 24 at screening. Patients with a history of or current alcohol dependence. Patients with a history or complication of brain disorders, including encephalitis, encephalopathy, traumatic brain injury, or cerebral infarction. Other patients judged by their primary physician to be inappropriate for participation in this study.

Design outcomes

Primary

MeasureTime frame
Inocum / Metric: Incidence of delirium during hospitalization Functional metrics of induced microglia-like (iMG) cells generated from blood samples (phagocytic activity, Ca2+ dynamics, production of inflammation-related substances, and responsiveness to BDNF) Comprehensive RNA expression levels in iMG cells Timepoint: From admission to discharge (or at the onset and resolution of delirium)

Secondary

MeasureTime frame
Inocum / Metric: Objective measurement scores extracted using AI from non-invasive devices (AI video monitors, simplified EEG, and wrist-worn activity trackers) Clinical factors (predisposing, precipitating, and contributing factors evaluated at admission and at the onset of delirium) Sequential changes in iMG cell RNA expression at multiple timepoints (at admission, delirium onset, and delirium resolution) Timepoint: At admission, at the onset of delirium, and upon resolution of delirium

Countries

Japan

Contacts

Public ContactTakumi Shiraishi

Saga University, Faculty of Medicine Department of Psychiatry

su1891@cc.saga-u.ac.jp+81-952-34-2304

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026