Clinical trial NCT06739187: Virtual Reality for Cognitive Impairment in Hemodialysis
Official title: Virtual Reality Training for Cognitive Impairment in Adults Treated With Hemodialysis: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hemodialysis
Keywords: hemodialysis
virtual reality
RCT
kidney failure
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: University of Bari Aldo Moro
name: University of Otago
First posted: 2024-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult participants aged 18 years or older and less than or equal to 75 years of age
* 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:

* Severe cognitive impairment or psychiatric diseases leading to inability to follow instructions and use the virtual reality headset
* 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

Primary outcomes:
measure: Accept the invitation to participate
timeFrame: 4, 12 weeks
measure: Appropriateness of eligibility criteria
timeFrame: 12 weeks
measure: Retention
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
measure: Proportion of adverse events
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 0, 4, 12, 24 weeks
Secondary outcomes:
measure: Depression
timeFrame: 0, 4, 12, 24 weeks
measure: Anxiety
timeFrame: 0, 4, 12, 24 weeks
measure: Quality of life
timeFrame: 0, 4, 12, 24 weeks
measure: Fatigue
timeFrame: 0, 4, 12, 24 weeks
measure: Health utility
timeFrame: 0 and 12 weeks
measure: All-cause death
timeFrame: 12 weeks
measure: Cardiovascular events
timeFrame: 12 weeks
measure: Pulse
timeFrame: 0 and 12 weeks
measure: Systolic blood pressure
timeFrame: 0 and 12 weeks
measure: Diastolic blood pressure
timeFrame: 0 and 12 weeks
measure: Functional near-infrared spectroscopy
timeFrame: 0 and 12 weeks
measure: Kt/V
timeFrame: 0 and 12 weeks
measure: Dialysis duration
timeFrame: 0 and 12 weeks
measure: Type of dialysis
timeFrame: 0 and 12 weeks
measure: Hemoglobin
timeFrame: 0 and 12 weeks
measure: Glucose
timeFrame: 0 and 12 weeks
measure: Glycated hemoglobin
timeFrame: 0 and 12 weeks
measure: Serum creatinine
timeFrame: 0 and 12 weeks
measure: Serum albumin
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari
state: BA
city: Naples
country: Italy
facility: Univerity Vanvitelli
Study officials:
References: