Virtual Reality for Cognitive Impairment in Hemodialysis
NCT ID: NCT06739187
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-04-01
2026-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Virtual reality
Participants will use the virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks.
Virtual reality platform on head mounted display
Enhance Virtual Reality platform on a Meta Quest head mounted display
Standard care
Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual reality platform on head mounted display
Enhance Virtual Reality platform on a Meta Quest head mounted display
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Receiving haemodialysis treatment for kidney failure for at least 90 days (permanent reduction in kidney function below an estimated glomerular filtration rate of 15 mL/minute per 1.73 m2)
* Able to provide written and informed consent
* Able to use the immersive virtual reality headset and follow instructions with sufficient motor, visual and auditory function to interact with the intervention
* Able to speak and understand Italian language
Exclusion Criteria
* Significant nystagmus and/or vertigo leading to inability to tolerate the virtual reality headset
* Insufficient motor function to use the virtual reality system
* Hearing or visual disability
* Advanced or uncompensated chronic diseases unrelated to kidney failure (e.g. advanced cancer, heart failure, lung diseases with poor oxygen saturation)
* Other neurological diseases (ictus, Alzheimer's or other forms of dementia)
* Persistent pain or itch or who using opioids that may interfere with the tests or any other condition that the clinician may judge as influencing the results
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sydney
OTHER
University of Bari Aldo Moro
OTHER
University of Otago
OTHER
University of Campania Luigi Vanvitelli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Davide Viggiano
Prof
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Bari
Bari, BA, Italy
Univerity Vanvitelli
Naples, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Giovanni Strippoli, Prof
Role: primary
Davide Viggiano, Prof
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRIN20225JEHW8
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PRIN20225JEHW8
Identifier Type: -
Identifier Source: org_study_id