NCT06999668

Prospective Randomized Controlled Trial of VR Cognitive Training in Reducing Postoperative Delirium in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical study investigates whether virtual reality (VR)-based cognitive training can help prevent postoperative delirium (POD) in elderly non-cardiac patients with pre-existing cerebral small vessel disease (CSVD). With the global aging population undergoing more surgical procedures, POD has emerged as a serious complication in surgical patients that can prolong hospital stays and increase the risk of developing Alzheimer's disease. The study utilizes an innovative VR system that combines eye-tracking cognitive assessment with interactive rehabilitation games to evaluate and train patients' cognitive function before non-cardiac and non-intracranial operations. Conducted at Peking University Third Hospital and First Hospital, this research specifically targets patients undergoing general surgery, orthopedic surgery and other non-intracranial/non-cardiac procedures to determine if this technology-based intervention can effectively reduce POD incidence in this population while exploring its underlying mechanisms. The findings could lead to a practical solution for protecting cognitive health in elderly patients undergoing routine surgical procedures during recovery

Conditions

• Postoperative Delirium (POD)
• Cerebral Small Vessel Diseases

Interventions

Type	Name	Description
DEVICE	Virtual reality cognitive function training	Participants will receive VR-based cognitive training over 4-5 days prior to surgery, with three daily 30-minute sessions (8:00-10:00 AM, 12:00-2:00 PM, and 5:00-7:00 PM), ensuring a total preoperative training duration ≥6 hours. The intervention utilizes an immersive VR environment that simulates real-world scenarios and tasks. Training modules target multiple cognitive domains, including memory, executive function, calculation, and abstract reasoning, designed as engaging, game-like activities with a gradual learning curve. Each participant's regimen is personalized based on baseline cognitive assessments or physician prescriptions, adhering to the "6-hour rule" for standardized efficacy evaluation. The system incorporates adaptive difficulty adjustment, dynamically modifying task complexity in response to real-time performance.
DEVICE	Virtual scene intervention	The control group will receive non-interactive VR exposure using identical equipment and session duration as the training group (3×30-minute daily sessions for 4-5 days, totaling ≥6 hours), with all interactive functions disabled to eliminate potential media-related biases (e.g., 2D/3D cognitive load differences from tablet-based interventions) and ensure between-group differences stem solely from interactive training while maintaining blinding integrity through equivalent hardware deployment.

Timeline

• Start date: 2025-05-31
• Primary completion: 2027-11-30
• Completion: 2027-12-31
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

2 sites across 1 country: China