Virtual Reality for Cognitive Impairment in Hemodialysis

Phase 2

Not yet recruiting

• Conditions: Hemodialysis

• Registration Number: NCT06739187
• Lead Sponsor: University of Campania Luigi Vanvitelli

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2025-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability	12 weeks	Proportion of randomized participants who complete \>80% of the treatments during 12 weeks follow-up.
Accept the invitation to participate	4, 12 weeks	Proportion of screened patients who participate in one or more sessions of allocated virtual reality training.
Appropriateness of eligibility criteria	12 weeks	Recruitment rate during 12 weeks of recruitment phase.
Retention	12 weeks	Proportion of randomized participants who complete the intervention and complete follow-up at 12 weeks.
Proportion of adverse events	12 weeks	Proportion of randomized participants who have adverse event reporting completed at 12 weeks.
Quality of life	0, 4, 12, 24 weeks	Proportion of randomized participants who complete the outcome measurements using the Kidney Disease Quality of Life Short Form 36 (KDQOL-36). The KDQOL-36 has five scales, including two generic health related quality of life scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each of the KDQOL-36 kidney-targeted scales are scored by transforming all items linearly to a 0-100 possible range and averaging the items in the scale. On the KDQOL-36, higher scores indicate better health realated quality of life.

Secondary Outcome Measures

Name	Time	Method
Depression	0, 4, 12, 24 weeks	Proportion of randomized participants who complete the outcome measurements using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided in two seven-item subscales. The total score for each subscale ranges from 0 to 21. In general a score ≤7 corresponds to "no depression or anxiety," a score of 8-10 is a minor depression/anxiety, a score of 11-15 a moderate depression/anxiety and a score ≥16 is defined as severe depression/anxiety.
Anxiety	0, 4, 12, 24 weeks	Proportion of randomized participants who complete the outcome measurements using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided in two seven-item subscales. The total score for each subscale ranges from 0 to 21. In general a score ≤7 corresponds to "no depression or anxiety," a score of 8-10 is a minor depression/anxiety, a score of 11-15 a moderate depression/anxiety and a score ≥16 is defined as severe depression/anxiety.
Quality of life	0, 4, 12, 24 weeks	Proportion of randomized participants who complete the outcome measurements using the 5-level EQ-5D version (EQ-5D-5L). In the EQ-5D-5L scores range from 0 to 100, where 100 is the best possible health related quality of life.
Fatigue	0, 4, 12, 24 weeks	Proportion of randomized participants who complete the outcome measurements using the Kidney Disease Quality of Life Short Form 36 (KDQOL-36). The KDQOL-36 has five scales, including two generic health related quality of life scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each of the KDQOL-36 kidney-targeted scales are scored by transforming all items linearly to a 0-100 possible range and averaging the items in the scale. On the KDQOL-36, higher scores indicate better outcome.
Health utility	0 and 12 weeks	Proportion of randomized participants who complete an authors' designed questionnaire
All-cause death	12 weeks	All-cause death reported during the study
Cardiovascular events	12 weeks	All cardiovascular events (myocardial infarction, stroke, peripheral arterial event) reported during the study
Pulse	0 and 12 weeks	Pulse rate (bpm)
Systolic blood pressure	0 and 12 weeks	Systolic blood pressure (mmHg)
Diastolic blood pressure	0 and 12 weeks	Diastolic blood pressure (mmHg)
Functional near-infrared spectroscopy	0 and 12 weeks	Functional near-infrared spectroscopy (fNIR)
Kt/V	0 and 12 weeks	Kt/V
Dialysis duration	0 and 12 weeks	Dialysis duration (min)
Type of dialysis	0 and 12 weeks	Type of dialysis
Hemoglobin	0 and 12 weeks	Hemoglobin (g/dL)
Glucose	0 and 12 weeks	Glucose (mg/dL)
Glycated hemoglobin	0 and 12 weeks	HbA1c (%)
Serum creatinine	0 and 12 weeks	Serum creatinine (mg/dL)
Serum albumin	0 and 12 weeks	Serum albumin (g/dL)

Trial Locations

Locations (2)

University of Bari; 🇮🇹 Bari, BA, Italy

Univerity Vanvitelli; 🇮🇹 Naples, Italy