An interventional study of MLP-based Clinical Decision Support System (MLP-CDSS) and VR-based Cognitive Intervention in Delirium in the Intensive Care Unit and Sleep Quality, sponsored by Taipei Medical University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Prevention
Delirium affects up to 83% of mechanically ventilated patients in the Intensive Care Unit (ICU), often leading to longer hospital stays and long-term memory or cognitive problems. While standard care protocols (such as the ABCDEF bundle) exist, they are often difficult to implement fully due to their complexity and the heavy workload on nursing staff.
To address these challenges, this study introduces a 'Precision Nursing' approach by integrating Artificial Intelligence (AI) and Virtual Reality (VR). We will implement an AI-driven system to assist nurses in making personalized care decisions more efficiently. Additionally, interactive VR technology will be used to stimulate patients' cognitive function and encourage early mobility. Our goal is to reduce the clinical burden on healthcare providers while significantly improving recovery outcomes for ICU patients.
Delirium affects up to 83% of ventilated ICU patients, necessitating precise non-pharmacological interventions like the SCAN-D program, which aims to improve outcomes by integrating smart computing and virtual reality into nursing decisions. This three-year, assessor-blinded, parallel randomized controlled trial will enroll 188 patients, assigning them to either usual care or the SCAN-D group, where the latter receives personalized strategies based on machine learning risk weights, including family-supervised immersive VR exercise and cognitive training. Throughout their stay, patients will be monitored via shift-based assessments (ICDSC/RASS) and nightly sleep tracking using actigraphy combined with one-lead EEG, while long-term cognitive function and quality of life (EQ-5D-3L) will be evaluated at three and six months post-discharge. The primary outcomes are the incidence of delirium and delirium-free days within the first 28 days of ICU admission, measured using the ICU Delirium Screening Checklist. Secondary outcomes include sleep quality and quantity, functional status during the ICU stay, ICU length of stay, duration of mechanical ventilation, total hospital length of stay, ICU mortality rate, Sedative and Analgesic Loading, 90-day Mortality Post-discharge, cognitive function, and quality of life. Finally, the collected data will be analyzed using SPSS 22.0 through independent t-tests, Chi-square tests, and Generalized Estimating Equations (GEE) to determine the program's efficacy in reducing delirium incidence and enhancing overall patient recovery.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 188 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Taipei Medical University is the lead sponsor of 257 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
The algorithm will calculate variable weights and select features contributing to 80% of the risk. These variables will guide the implementation of personalized delirium prevention strategies, with making decision based on nurses' clinical expertise.
Device: MLP-based Clinical Decision Support System (MLP-CDSS) · Behavioral: VR-based Cognitive Intervention · Behavioral: VR-assisted Early Mobility Exercise
The control group will receive routine care, including delirium assessments and sleep environment management.
An AI-integrated system utilizing a Multilayer Perceptron (MLP) model to predict delirium risk and guide targeted interventions. The system continuously analyzes real-time data from Electronic Health Records (EHR), including physiological parameters, medication history, and laboratory results.
A virtual reality intervention designed to provide cognitive stimulation and reduce sensory deprivation. Patients engage in interactive games (e.g., traditional-themed tasks such as goldfish scooping or lantern festivals) that require attention, memory, and spatial orientation. These sessions are conducted twice daily for total 30-40 minutes, 3-4 times a week.
A VR-based physical activity program focused on promoting upper limb movement and range of motion. The virtual environment encourages patients to perform specific gestures or reaching tasks while in bed or a seated position, aiming to improve mobility and reduce the physical deconditioning common in ICU stays. These sessions are conducted twice daily for total 30-40 minutes, 3-4 times a week.
Incidence of ICU delirium
The proportion of participants who develop delirium during their ICU stay. Delirium is assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The checklist evaluates 8 clinical signs, with each item scored 0 or 1. A total score of 4 or higher is defined as a "positive" delirium diagnosis.
Time frame: From ICU admission to ICU discharge or maximum 28 days, assessed per shift
Delirium-Free Days
The number of days alive and free of delirium during ICU stay. Delirium status is assessed daily using the Intensive Care Delirium Screening Checklist (ICDSC). A "delirium-free day" is defined as a calendar day on which the patient is alive and has an ICDSC score of less than 4
Time frame: Through Day 28 after ICU admission.
Subjective Sleep Quality
Daily sleep quality as perceived by the participant, measured using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a 5-item visual analog scale that assesses: * Sleep depth * Sleep latency (falling asleep) * Number of awakenings * Time to return to sleep * Overall sleep quality. Each item is scored from 0 to 100 mm. The total score is the average of the five items. The total score ranges from 0 to 100, where higher scores indicate better sleep quality.
Time frame: Daily from enrollment until ICU discharge or up to a maximum of 28 days.
Objective Sleep Quality
Description: Objective sleep status will be evaluated by SOMNOwatch™, which can extract not only sleep related parameters but also calculate sleep stages using additional electroencephalography (EEG) sensors.
Time frame: Continuous monitoring every night from enrollment until ICU discharge or up to a maximum of 28 days.
ICU Mortality
The number of participants who died during their stay in the Intensive Care Unit.
Time frame: From ICU admission to ICU discharge (estimated up to 28 days)
90-day All-cause Mortality
The number of participants who died from any cause within 90 days following discharge from the hospital.
Time frame: 90 days after hospital discharge.
Cumulative Dose of Sedatives and Analgesics
The total cumulative dose of sedatives (e.g., Propofol, Midazolam) and analgesics (e.g., Fentanyl, Morphine) administered during the ICU stay. To allow comparison, doses will be converted to equivalents (e.g., Midazolam equivalents for sedatives and Morphine equivalents for analgesics).
Time frame: Daily during the ICU stay, up to 28 days.
Hospital Length of Stay (LOS)
The total number of days from study enrollment to hospital discharge or death.
Time frame: From study enrollment to hospital discharge (expected up to 3 month).
ICU-related Adverse Events
The frequency and type of adverse events occurring in the ICU, including but not limited to: unplanned extubation, falls, pressure ulcers, and ventilator-associated pneumonia (VAP).
Time frame: Throughout the ICU stay, up to 28 days
ICU Length of Stay (ICU LOS)
The total number of days the participant remains in the Intensive Care Unit, calculated from the date of ICU admission to the date of ICU discharge or death.
Time frame: From ICU admission to ICU discharge (estimated up to 28 days).
Health-Related Quality of Life
The Euro Qol Five-Dimensional Five-Level Scale (EQ-5D-5L) is used to evaluate health-related QoL. The health status classification comprises five dimensions, each with five levels, calculated using specific values. The vertical analog scale assesses the patient's overall evaluation of their current health status, ranging from 0 to 100. Higher scores indicate greater QoL.
Time frame: At 3 months and 6 months after hospital discharge.
Duration of Mechanical Ventilation
The total number of days during which the participant requires mechanical ventilation support while in the Intensive Care Unit. This includes both invasive (via endotracheal tube or tracheostomy) and non-invasive ventilation (NIV). The duration is calculated from the initiation of mechanical ventilation to successful weaning and extubation.
Time frame: Throughout the ICU stay, from enrollment up to a maximum of 28 days.
Long-term Cognitive Function
Cognitive performance assessed via the Telephone Interview for Cognitive Status (TICS). The TICS is an 11-item screening instrument specifically designed for telephone administration to patients who cannot be assessed in person. The total score ranges from 0 to 41, where higher scores indicate better cognitive performance.
Time frame: At 3 months and 6 months after hospital discharge.
Start is estimated for Jun 2026; primary completion for Jan 2028, 19 months later.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 19 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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