UMIN-ICDS Clinical Trial

Public title

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

Acronym

AIDE-P

Scientific Title

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

Scientific Title:Acronym

AIDE-P Project

Region

Japan

Condition

delirium

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Although delirium is a critical condition leading to poor prognosis and significant healthcare costs, its underlying pathophysiology remains poorly understood. This study focuses on neuroinflammation, specifically the involvement of microglia in delirium.
Using blood samples from patients admitted to the Emergency Care Unit (ECU) or orthopedic ward, we will generate induced microglia-like (iMG) cells. We aim to statistically investigate the role of microglia in delirium by comparing iMG cells between patients who develop delirium and those who do not, focusing on phagocytic activity, Ca2+ dynamics, production of inflammation-related substances, and responsiveness to brain-derived neurotrophic factor (BDNF).
The ultimate objective of this study is to establish a foundation for developing novel strategies for the prediction, prevention, and treatment of delirium targeting microglia.
(Note: Any secondary use of the data obtained in this study will be conducted only after obtaining separate approval from the Institutional Review Board.)

Basic objectives2

Others

Basic objectives -Others

This is an interventional study involving procedures beyond routine clinical care (application of a simplified EEG, additional blood sampling for research purposes, and video recording). Rather than a clinical trial for the regulatory approval of a new drug or medical device, the objective regarding safety and efficacy is to exploratorily evaluate the "utility for delirium prediction (efficacy)" and the "feasibility and patient burden of these measurement devices (safety)."

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

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)

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

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] Preoperative cognitive function will be assessed using the MMSE; 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 assessments will be performed. That night, a simplified EEG and a wrist-worn activity tracker will be applied.
3. [During ICU Stay] Continuous monitoring via ICU video recording, simplified EEG, and activity tracker will be conducted from ICU admission to discharge (daytime music therapy will be applied upon request). Delirium will be assessed every 8 hours using the CAM-ICU. At the time of suspected delirium onset, or at 48 hours post-awakening without delirium, DRS-R98/MMSE assessments and research-specific blood sampling (approx. 70 mL) will be performed.
4. [Pre-discharge Evaluation] On the day before discharge, DRS-R98/MMSE assessments and blood sampling (approx. 70 mL) will be conducted, followed by overnight simplified EEG and activity tracking.

[Analysis Items]
Monocytes isolated from blood samples will be cultured to generate induced microglia-like (iMG) cells for RNA expression analysis. Inflammatory markers (high-sensitivity CRP, IL-1beta, TNF-alpha) will be measured from the remaining serum. EEG, actigraphy, and video recording (motion analysis) data will be utilized for AI-based multi-omics analysis and integrated with clinical data (demographics, medical history, routine laboratory data, and DRS-R98 scores) to develop a delirium prediction model.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

70

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key 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.

Key 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.

Target sample size

36

Name of lead principal investigator

1st name	Toru
Middle name
Last name	Murakawa-Hirachi

Organization

Saga University, Faculty of Medicine

Division name

Department of Psychiatry

Zip code

849-8501

Address

Saga Prefecture, Saga City, Nabeshima 5-1-1

TEL

+81-952-34-2304

Email

si5059@cc.saga-u.ac.jp

Name of contact person

1st name	Takumi
Middle name
Last name	Shiraishi

Organization

Saga University, Faculty of Medicine

Division name

Department of Psychiatry

Zip code

849-8501

Address

Saga Prefecture, Saga City, Nabeshima 5-1-1

TEL

+81-952-34-2304

Homepage URL

Email

su1891@cc.saga-u.ac.jp

Institute

Saga University

Institute

Department

Personal name

Toru Murakawa-Hirachi

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Center, Saga University Hospital

Address

Saga Prefecture, Saga City, Nabeshima 5-1-1

Tel

+81-952-34-2304

Email

medsosou@mail.admin.saga-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

06

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2025

Year

10

Month

01

Day

Date of IRB

2025

Year

10

Month

01

Day

Anticipated trial start date

2026

Year

06

Month

16

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

06

Month

16

Day

Last modified on

2026

Year

06

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070867