NCT06739187

Virtual Reality for Cognitive Impairment in Hemodialysis

Virtual Reality Training for Cognitive Impairment in Adults Treated With Hemodialysis: A Feasibility Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized feasibility clinical trial is to identify participant recruitment and retention, acceptability, and adherence to virtual reality training in people undergoing hemodialysis. The main question it aims to answer is if virtual reality could be a feasible and acceptable intervention in this setting. The investigators will compare participants on virtual reality training during the standard dialysis session with those treated with standard dialysis session alone to see if a cognitive training using immersive virtual reality in people on hemodialysis is feasible and acceptable. Participants randomised in the intervention group will use virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks. The virtual reality intervention will consist of computerized cognitive training of 4 games. Each exercise delivered to the participant will specifically provide training in a specific cognitive category (memory, cognitive flexibility, processing, attention, and memory). Participants randomised in the control group will perform the standard hemodialysis session three times a week for 12 weeks, without using virtual reality.

Detailed description

The trial is a multicenter, parallel group, feasibility randomized controlled trial. The trial population will include adult participants, who have the physical and cognitive capacity to be trained using immersive virtual reality and who have kidney failure on hemodialysis. Participants will be allocated in the intervention (virtual reality session) or standard of care without the intervention. Participants will be allocated to intervention or standard care by randomization 1:1. The virtual reality intervention will consist of computerized cognitive training of a subset of 4 short, gamified exercises. The intervention will be accessed through the Enhance VR platform on a Meta Quest 3S head mounted display, Snapdragon XR2 Gen2, processor, 8 Gb RAM, 128 Gb internal memory, resolution per eye in pixels: 1832 x 1920 with a refresh rate of 90-120 Hz and motion controllers. The clinician responsible for the intervention will be in the room with the participant, providing support for the intervention and any technical issues. The chosen trial duration of 12 weeks is designed to provide exposure to a meaningful dose of cognitive training (three times a week) aligned to previous similar studies and to maximize participant tolerability to immersive virtual reality training. The endpoints described in this protocol align with the recommendations of the CONSORT 2010 statement: extension to randomized pilot and feasibility studies. The endpoints are specifically chosen to relate to feasibility. The outcomes also include the primary and secondary outcomes for the future definitive randomized controlled trial to assess response, feasibility of measurement, and completeness.

Conditions

• Hemodialysis

Interventions

Type	Name	Description
DEVICE	Virtual reality platform on head mounted display	Enhance Virtual Reality platform on a Meta Quest head mounted display

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

2 sites across 1 country: Italy