HemodialysisPhase 2VIRTUALNCT06739187
Virtual Reality for Cognitive Impairment in Hemodialysis
A Phase 2 study testing Virtual reality platform on head mounted display in people with Hemodialysis, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Virtual reality platform on head mounted display
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Apr 2025to 1 Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
University of Bari
Bari, BA, 70124
Giovanni Strippoli, Prof, 0805591111, giovanni.strippoli@uniba.it
Univerity Vanvitelli
Naples, 80133
Davide Viggiano, Prof, 0815664282, davide.viggiano@unicampania.it
About this study
Official title: Virtual Reality Training for Cognitive Impairment in Adults Treated With Hemodialysis: A Feasibility Randomized Controlled Trial
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.
Read the 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
- Being tested
- Virtual reality platform on head mounted display
- Keywords
- hemodialysis, virtual reality, RCT, kidney failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality platform on head mounted displayDevice
Enhance Virtual Reality platform on a Meta Quest head mounted display
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Active comparator | Participants will use the virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks. Receives: Device: Virtual reality platform on head mounted display |
| Standard care | No intervention | Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accept the invitation to participate
Proportion of screened patients who participate in one or more sessions of allocated virtual reality training.
Measured: 4, 12 weeks
Appropriateness of eligibility criteria
Recruitment rate during 12 weeks of recruitment phase.
Measured: 12 weeks
Retention
Proportion of randomized participants who complete the intervention and complete follow-up at 12 weeks.
Measured: 12 weeks
Acceptability
Proportion of randomized participants who complete >80% of the treatments during 12 weeks follow-up.
Measured: 12 weeks
Proportion of adverse events
Proportion of randomized participants who have adverse event reporting completed at 12 weeks.
Measured: 12 weeks
Quality of life
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.
Measured: 0, 4, 12, 24 weeks
Secondary outcomes (19)
Depression
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.
Measured: 0, 4, 12, 24 weeks
Anxiety
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.
Measured: 0, 4, 12, 24 weeks
Quality of life
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.
Measured: 0, 4, 12, 24 weeks
Fatigue
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.
Measured: 0, 4, 12, 24 weeks
Health utility
Proportion of randomized participants who complete an authors' designed questionnaire
Measured: 0 and 12 weeks
All-cause death
All-cause death reported during the study
Measured: 12 weeks
Cardiovascular events
All cardiovascular events (myocardial infarction, stroke, peripheral arterial event) reported during the study
Measured: 12 weeks
Pulse
Pulse rate (bpm)
Measured: 0 and 12 weeks
Systolic blood pressure
Systolic blood pressure (mmHg)
Measured: 0 and 12 weeks
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Measured: 0 and 12 weeks
Functional near-infrared spectroscopy
Functional near-infrared spectroscopy (fNIR)
Measured: 0 and 12 weeks
Kt/V
Kt/V
Measured: 0 and 12 weeks
Dialysis duration
Dialysis duration (min)
Measured: 0 and 12 weeks
Type of dialysis
Type of dialysis
Measured: 0 and 12 weeks
Hemoglobin
Hemoglobin (g/dL)
Measured: 0 and 12 weeks
Glucose
Glucose (mg/dL)
Measured: 0 and 12 weeks
Glycated hemoglobin
HbA1c (%)
Measured: 0 and 12 weeks
Serum creatinine
Serum creatinine (mg/dL)
Measured: 0 and 12 weeks
Serum albumin
Serum albumin (g/dL)
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, University of Bari Aldo Moro, University of Otago
- Responsible party
- Principal investigator, Davide Viggiano, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739187
- Sponsor's protocol ID
- PRIN20225JEHW8
- Other IDs
- PRIN20225JEHW8
- Acronym
- VIRTUAL
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available after request to the principal investigator.
Publications
Viggiano D, Pellegrino G, Natale P, Buonincontri V, Gigliotti G, Genualdo R, Nappi F, De Nicola L, Iodice C, Iannuzzi M, Iulianiello P, Auricchio MR, Zamboli P, Montinaro V, Strippoli G. Virtual reality training for cognitive impairment in adults treated with haemodialysis (VIRTUAL): protocol for a multicentre, randomised, open-label feasibility trial. BMJ Open. 2026 Jun 28;16(6):e120700. doi: 10.1136/bmjopen-2026-120700.
PubMed 42366016
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Training for Cognitive Impairment in Adults Treated With Hemodialysis: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06739187
- Acronym / sponsor ID
- VIRTUAL / PRIN20225JEHW8
- Conditions
- Hemodialysis
- Keywords
- hemodialysis, virtual reality, RCT, kidney failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- University of Sydney, University of Bari Aldo Moro, University of Otago
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Active comparator | Device: Virtual reality platform on head mounted displayParticipants will use the virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks. |
| Standard care | No intervention | –Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality platform on head mounted displayEnhance Virtual Reality platform on a Meta Quest head mounted display | Device | Virtual reality |
Primary outcome
Accept the invitation to participate
Time frame: 4, 12 weeks
Proportion of screened patients who participate in one or more sessions of allocated virtual reality training.
Appropriateness of eligibility criteria
Time frame: 12 weeks
Recruitment rate during 12 weeks of recruitment phase.
Retention
Time frame: 12 weeks
Proportion of randomized participants who complete the intervention and complete follow-up at 12 weeks.
Acceptability
Time frame: 12 weeks
Proportion of randomized participants who complete >80% of the treatments during 12 weeks follow-up.
Proportion of adverse events
Time frame: 12 weeks
Proportion of randomized participants who have adverse event reporting completed at 12 weeks.
Quality of life
Time frame: 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.
19 secondary outcomes
Depression
Time frame: 0, 4, 12, 24 weeks
Anxiety
Time frame: 0, 4, 12, 24 weeks
Quality of life
Time frame: 0, 4, 12, 24 weeks
Fatigue
Time frame: 0, 4, 12, 24 weeks
Health utility
Time frame: 0 and 12 weeks
All-cause death
Time frame: 12 weeks
Cardiovascular events
Time frame: 12 weeks
Pulse
Time frame: 0 and 12 weeks
Systolic blood pressure
Time frame: 0 and 12 weeks
Diastolic blood pressure
Time frame: 0 and 12 weeks
Functional near-infrared spectroscopy
Time frame: 0 and 12 weeks
Kt/V
Time frame: 0 and 12 weeks
Dialysis duration
Time frame: 0 and 12 weeks
Type of dialysis
Time frame: 0 and 12 weeks
Hemoglobin
Time frame: 0 and 12 weeks
Glucose
Time frame: 0 and 12 weeks
Glycated hemoglobin
Time frame: 0 and 12 weeks
Serum creatinine
Time frame: 0 and 12 weeks
Serum albumin
Time frame: 0 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 42366016Viggiano D, Pellegrino G, Natale P, Buonincontri V, Gigliotti G, Genualdo R, Nappi F, De Nicola L, Iodice C, Iannuzzi M, Iulianiello P, Auricchio MR, Zamboli P, Montinaro V, Strippoli G. Virtual reality training for cognitive impairment in adults treated with haemodialysis (VIRTUAL): protocol for a multicentre, randomised, open-label feasibility trial. BMJ Open. 2026 Jun 28;16(6):e120700. doi: 10.1136/bmjopen-2026-120700.
- Individual participant dataSharing planned: No. Data will be available after request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virtual reality platform on head mounted display in people with Hemodialysis, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accept the invitation to participate (time frame: 4, 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06739187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.