An interventional study of Supervised Virtual Reality Sessions in Dementia, Agitation and Behavioural and Psychological Symptoms of Dementia, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Not yet recruiting at 2 sites in Canada. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Supportive care
The goal of this feasibility clinical trial is to learn whether supervised virtual reality (VR) sessions can be safely and practically provided to adults aged 55 years and older with moderate-to-severe dementia who experience agitation while receiving care in inpatient geriatric psychiatry units.
The main questions this study aims to answer are:
Can participants be identified, enrolled, and retained in the study? Can participants tolerate and complete supervised VR sessions? Can clinical staff fit VR sessions into routine inpatient care? What safety or comfort concerns occur during or after VR sessions? Can the study team collect information needed to plan a larger future study?
Following informed consent, prospective participants will undergo screening to determine eligibility. Those who are eligible and enrolled will complete any remaining baseline assessments and will then be offered a brief VR familiarization or orientation procedure. Completion of tolerated familiarization is required before regular VR sessions may begin. Familiarization will not count as intervention initiation or as a regular VR intervention session. These activities form one continuous study period; there is no fixed observational or waiting period.
Participants who tolerate familiarization may be offered supervised VR sessions up to three times per week for up to six weeks, with a maximum of 18 regular sessions. Sessions will start at about 10 minutes and may increase gradually to about 30 minutes, depending on each participant's comfort and tolerance.
Familiarization and early VR exposure will begin with calming, low-stimulation, non-threatening virtual environments. Content may later be adjusted based on the participant's comfort, preferences, observed response, clinical appropriateness, and safety. Participants will remain seated and will be monitored by trained staff. Sessions will not start or will be stopped if the participant shows distress, discomfort, refusal, dizziness, nausea, confusion, worsening agitation, or any other safety concern.
Researchers will also collect information about agitation, behavioural symptoms, quality of life, medication use, staff experience, and workflow. This study is not designed to prove that VR treats agitation or dementia. The findings will be used to determine whether a larger future study is practical and how it should be designed.
VR-Care is a multi-site, investigator-initiated, single-arm feasibility study of virtual reality (VR) for adults aged 55 years and older with moderate-to-severe dementia and clinically significant agitation in inpatient geriatric psychiatry settings. The study does not include randomization, blinding, or a comparator group.
Agitation in dementia can include restlessness, pacing, repeated vocalizations, verbal aggression, physical aggression, emotional distress, or resistance to care. In inpatient care settings, agitation may be difficult to manage and can affect the person living with dementia, families, care partners, staff, and clinical workflow. Non-drug approaches are recommended in dementia care, but they can be difficult to deliver consistently in busy inpatient settings.
This study will examine whether supervised VR can be delivered safely, tolerably, acceptably, and practically in real-world inpatient geriatric psychiatry units. The primary focus is feasibility and implementation, not clinical efficacy.
Approximately 10 participants will be enrolled across two inpatient geriatric psychiatry units:
Finch Family Mental Health Care Building, St. Joseph's Health Care London; Victoria Hospital Geriatric Behavioural Unit, London Health Sciences Centre
Each participant will be followed for approximately seven weeks, when feasible, including screening, enrollment, baseline assessments, familiarization, up to six weeks of regular VR sessions, and end-of-study or early-termination assessments, as applicable.
Formal screening will begin after informed consent has been obtained from the prospective participant, if capable of consenting to this study, or from an authorized substitute decision maker, as applicable. Participant assent or behavioural willingness will be sought when applicable, and verbal or non-verbal refusal or distress will be respected throughout the study.
Screening, enrollment, baseline assessments, and familiarization will form one continuous study period. These activities may be completed on the same day or over more than one day, depending on respondent and staff availability, the participant's clinical status and readiness for familiarization, and unit workflow. There is no fixed observational or waiting period.
During screening, the study team will review the prospective participant's dementia diagnosis; relevant medical, psychiatric, neurological, behavioural, sensory, and safety history; medication use; and all other inclusion and exclusion criteria. The Cohen-Mansfield Agitation Inventory (CMAI) will be administered to document the nature and frequency of relevant agitated behaviours and to support the investigator's determination of whether the prospective participant meets the 2024 International Psychogeriatric Association definition of agitation in cognitive disorders. CMAI scores alone will not establish eligibility, and no numerical CMAI cutoff will be used. The Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) will be administered to assess behavioural and psychological symptoms and the applicable exclusion criterion concerning clinically significant delusions or hallucinations.
For participants who are eligible and enrolled, the screening CMAI and NPI-NH assessments will also serve as the corresponding baseline assessments. Remaining baseline assessments, completed after enrollment to the extent feasible, will include the proxy-rated Quality of Life in Alzheimer's Disease scale and a modified Clinical Global Impression-Severity agitation rating. Demographic, medication, and other relevant clinical and contextual information will also be documented.
Following enrollment and completion of the remaining baseline assessments to the extent feasible, every enrolled participant will be offered a brief VR familiarization or orientation procedure. Completion of tolerated familiarization is required before regular VR intervention sessions may begin. Familiarization will not constitute intervention initiation, will not count as a regular VR intervention session, and will not be included in intervention-adherence calculations. An enrolled participant who does not tolerate familiarization and does not begin a regular VR session will be classified as an enrolled non-initiator rather than a screen failure, and the reason will be documented.
Participants who tolerate familiarization may be offered up to three regular VR sessions per week for up to six weeks, with a maximum of 18 regular sessions. Regular sessions will begin at approximately 10 minutes and may gradually increase to approximately 30 minutes, as tolerated. Participants will not be required to reach the maximum session length.
VR content will be selected from the Rendever platform content library using a graded, participant-centred approach. Familiarization and early VR exposure will begin with calming, low-motion, low-stimulation, non-threatening experiences. Content may later be adjusted based on the participant's comfort, preferences, observed responses, staff or family input, clinical appropriateness, and safety considerations. Highly stimulating, fast-moving, disorienting, flashing, frightening, or otherwise distressing content will not be used.
Only a randomly assigned study identification code may be entered into the Rendever platform. Participant names, other identifying information, clinical assessment information, and participant-provided photographs, videos, or recordings will not be entered or uploaded. The study will not use the AI Guide or AI Companion, voice or audio recording or transcription, participant media-upload features, or other unused social or participant-profile features.
Trained staff will deliver VR sessions within routine inpatient care workflows, with research-team oversight. Before familiarization and every regular VR session, staff will complete a safety and readiness check and confirm the participant's willingness to proceed. Participants will remain seated during VR exposure.
Familiarization or a regular VR session will not proceed or will be stopped early if the participant shows verbal or non-verbal refusal, distress, dizziness, nausea, confusion, disorientation, worsening agitation, fear, unsafe movement, attempts to remove the headset, or any other safety concern.
For each prospectively planned regular session, the study team will document whether the session was offered, initiated, completed as tolerated, stopped early, deferred, or not conducted, together with the reason. Participant refusal, intolerance, missed or deferred sessions, interrupted sessions, and permanent discontinuation of VR will be documented as feasibility, tolerability, and session-delivery outcomes. Initiation of at least one regular VR session, including a first session that is stopped early, will constitute intervention exposure.
The Pittsburgh Agitation Scale will be completed immediately before and after each regular VR intervention session, as feasible and clinically appropriate, to describe immediate changes in agitation associated with individual sessions. Other participant assessments will be completed at the protocol-specified timepoints, including end-of-study or early-termination assessments when applicable and feasible.
Participants will continue to receive standard inpatient clinical care throughout the study. The study will not prohibit, delay, or require changes to clinically indicated medication treatment, and there are no protocol-mandated medication washouts. Medication use will be documented descriptively as contextual information.
Familiarization and regular VR sessions will ordinarily be deferred for six hours after administration of an as-needed rescue medication for acute agitation or behavioural distress. Earlier VR exposure may occur only if the treating clinical team confirms that the participant has returned to their usual state and is clinically ready, all pre-session readiness criteria are satisfied, the reason for proceeding earlier is documented, and the Principal Investigator or Co-Principal Investigator authorizes the earlier exposure.
Safety monitoring will begin after informed consent and continue throughout study participation. Safety concerns, intolerance, adverse effects, early stopping, and permanent discontinuation related to VR will be documented.
Primary outcomes are feasibility and implementation outcomes. These include recruitment and participant flow, recruitment rate, intervention initiation, participant retention, final-assessment completion, intervention completion and disposition, adherence to planned regular VR sessions, intervention tolerability, safety, session-delivery feasibility, and staff implementation outcomes. Recruitment rate will use formally eligible individuals as its denominator. Participant retention and final-assessment completion will be measured and reported separately.
Staff acceptability, appropriateness, usability, implementation feasibility, perceived workload and workflow burden, and integration into routine care will be assessed through two complementary staff-feedback pathways using three study-specific questionnaires. Appropriately trained and PI/Site PI-delegated staff who serve as VR facilitators will be invited to complete a pre-implementation expectations questionnaire and a post-implementation experience questionnaire. Eligible frontline care staff, including registered nurses (RNs), registered practical nurses (RPNs), personal support workers (PSWs), and other unit staff directly involved in participant care, who have relevant direct experience with VR-Care and were not acting in a formal VR facilitator role may complete a separate one-time experience questionnaire. Routine operational discussions or troubleshooting outside these questionnaires will not be analyzed as staff-feedback research data.
Exploratory outcomes will describe agitation over time using standard CMAI frequency ratings, the perceived disruptiveness of agitated behaviours using CMAI disruptiveness ratings, immediate pre- to post-session agitation, broader behavioural and psychological symptoms, quality of life, clinician-rated global agitation severity, NPI-NH occupational disruptiveness, and medication-use patterns. These outcomes will be interpreted descriptively and cautiously because the study is small, single-arm, and not powered to establish clinical efficacy.
Findings from this study will be used to refine study procedures, safety monitoring, intervention delivery, staff training, outcome selection, and feasibility benchmarks for a future larger controlled trial.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's planned enrollment of 10 is below the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 328 studies on the registry; 133 are open to participants now.
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Presence of clinically significant agitation meeting the 2024 International Psychogeriatric Association (IPA) consensus clinical and research definition of agitation in cognitive disorders, as determined by the investigator using the CMAI together with other relevant clinical information. The prospective participant must:
The CMAI will be used to document the nature and frequency of relevant agitated behaviours during the preceding two weeks and to support the investigator's determination of whether the participant meets the 2024 IPA definition. CMAI scores alone will not establish eligibility.
Exclusion Criteria:
All enrolled participants will be offered a brief, supervised virtual reality (VR) familiarization or orientation procedure using commercially available VR headset technology and the Rendever platform content library. Completion of tolerated familiarization is required before regular VR intervention sessions may begin. Familiarization will not constitute intervention initiation and will not count as a regular VR session. Participants who tolerate familiarization may be offered up to three regular supervised VR sessions per week for up to six weeks, with a maximum of 18 regular sessions. Sessions will be delivered by appropriately trained and delegated staff in inpatient geriatric psychiatry units, with research-team oversight. Participants will continue to receive standard inpatient clinical care throughout study participation.
Behavioral: Supervised Virtual Reality Sessions
Participants who complete tolerated familiarization may be offered up to three supervised VR sessions per week for up to six weeks, with a maximum of 18 regular sessions. Sessions will begin at approximately 10 minutes and may gradually increase to approximately 30 minutes, as tolerated. VR content will follow a graded, participant-centred approach, beginning with calming, low-motion, low-stimulation, non-threatening experiences and later being adjusted based on participant comfort, preferences, observed responses, clinical appropriateness, and safety. Appropriately trained and delegated staff will supervise each session and confirm participant readiness and willingness before each VR exposure. Sessions will be deferred, not initiated, or stopped early if refusal, distress, discomfort, dizziness, nausea, confusion, worsening agitation, unsafe movement, or another safety concern occurs.
Recruitment feasibility and recruitment rate
Recruitment flow will be summarized using the numbers and proportions of potentially eligible individuals identified or referred, proceeding to informed consent, meeting formal eligibility criteria, and enrolling. Recruitment rate will be calculated as the number of formally eligible individuals enrolled divided by the total number of formally eligible individuals.
Time frame: From start of recruitment through completion of enrollment, anticipated up to approximately 14 months
Participant retention rate
Participant retention rate will be calculated as the proportion of enrolled participants who remain in study follow-up through the planned end-of-study timepoint, whether or not they complete all planned regular VR sessions. Completion of an end-of-study or early-termination assessment will be measured separately.
Time frame: From enrollment through the planned end-of-study timepoint, up to approximately 7 weeks per participant
Intervention initiation rate
Intervention initiation rate will be calculated as the proportion of enrolled participants who initiate at least one regular VR intervention session. Familiarization or orientation will not constitute intervention initiation.
Time frame: From enrollment through the first regular VR intervention session or determination of non-initiation, anticipated within approximately 2 weeks per participant
Intervention adherence and session completion
Intervention adherence will be calculated among participants who initiate at least one regular VR intervention session as the number of participant-specific planned regular VR sessions completed as tolerated divided by the total number of participant-specific planned regular VR sessions. Participants may have up to 18 planned regular VR sessions over up to six weeks. Familiarization will be excluded from the adherence calculation.
Time frame: During the VR intervention period, up to approximately 6 weeks
Session-delivery feasibility
Prospectively planned regular VR sessions that are offered but not initiated, stopped early, deferred, or not conducted will be summarized by frequency and reason. Reasons may include participant refusal or unavailability, clinical or safety considerations, discharge or transfer, medication-related timing, staffing or workflow limitations, infection-prevention requirements, or device and technical problems.
Time frame: During the VR intervention period, up to approximately 6 weeks
Intervention completion and disposition
The numbers and proportions of enrolled participants who complete the planned VR intervention period, permanently discontinue VR before the planned end of the intervention period, or terminate study participation early will be summarized, together with the reasons.
Time frame: From enrollment through end-of-study or early termination, up to approximately 7 weeks per participant
Intervention tolerability
Intervention tolerability will be summarized using the number and proportion of regular VR sessions associated with intolerance or early stopping, the types and outcomes of tolerability events, and the number and proportion of intervention-exposed participants who permanently discontinue VR because of VR-related intolerance or adverse effects.
Time frame: During the VR intervention period, up to approximately 6 weeks
Safety and session-level tolerability events
Adverse events and serious adverse events will be summarized by frequency, type, severity, seriousness, relationship to VR or study procedures, action taken, and outcome. Session-level intolerance or tolerability events and other safety concerns associated with VR exposure or study participation will also be summarized descriptively.
Time frame: From informed consent through end-of-study or early termination, up to approximately 7 weeks per enrolled participant
Staff acceptability, appropriateness, usability, implementation feasibility, perceived workload and workflow burden, and workflow integration
Staff implementation outcomes will be assessed through two complementary staff-feedback pathways using three study-specific questionnaires: matched pre- and post-implementation questionnaires for appropriately trained and PI/Site PI-delegated VR facilitators, and a separate one-time questionnaire for eligible frontline care staff with relevant direct experience who are not acting as formal VR facilitators. Outcomes include acceptability, appropriateness, usability, implementation feasibility, perceived benefits and concerns, training and support, workload and workflow fit, barriers, facilitators, sustainability, and recommendations for future implementation.
Time frame: From completion of facilitator training/orientation through the end of relevant staff involvement or intervention delivery, through study completion, anticipated up to approximately 15 months
Final-assessment completion rate
Final-assessment completion rate will be calculated as the proportion of enrolled participants who complete an end-of-study or early-termination assessment. This outcome will be reported separately from participant retention.
Time frame: From enrollment through end-of-study or early termination, up to approximately 7 weeks per participant
Change in agitation over time measured by the Cohen-Mansfield Agitation Inventory
Agitation over time will be measured using the Cohen-Mansfield Agitation Inventory (CMAI). The CMAI includes 29 agitated behaviours rated on a 7-point frequency scale. Total scores range from 29 to 203, with higher scores indicating greater frequency of agitated behaviours. Scores will be summarized descriptively to explore changes in agitation from baseline through the intervention period and at end-of-study or early termination.
Time frame: Baseline, every 2 weeks during the intervention period, and end-of-study or early termination, up to approximately 7 weeks per participant
Change in perceived disruptiveness of agitated behaviours measured using CMAI disruptiveness ratings
Perceived disruptiveness of agitated behaviours will be assessed using CMAI disruptiveness ratings collected alongside the standard CMAI frequency ratings. Disruptiveness reflects how disturbing individual agitated behaviours are perceived to be. Ratings will be summarized separately and descriptively from CMAI frequency ratings to explore changes in the perceived disruptiveness of agitated behaviours over time. CMAI disruptiveness ratings will not be used to determine eligibility.
Time frame: Baseline, every 2 weeks during the intervention period, and end-of-study or early termination, up to approximately 7 weeks per participant
Immediate pre- to post-session change in agitation measured by the Pittsburgh Agitation Scale
Immediate within-session change in observed agitation will be measured using the Pittsburgh Agitation Scale, completed immediately before and after each regular VR intervention session, as feasible and clinically appropriate. The PAS assesses observable agitation across four behavioural domains: aberrant vocalization, motor agitation, aggressiveness, and resistance to care. Higher scores indicate greater observed agitation. Scores will be summarized descriptively to explore short-term changes associated with individual regular VR sessions.
Time frame: Immediately before and after each regular VR intervention session, as feasible and clinically appropriate, up to 18 sessions over 6 weeks
Change in behavioural and psychological symptoms measured by the Neuropsychiatric Inventory - Nursing Home Version
Behavioural and psychological symptoms of dementia will be measured using the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). The NPI-NH assesses neuropsychiatric symptom domains using frequency and severity ratings. Higher scores indicate greater neuropsychiatric symptom burden. Scores will be summarized descriptively to explore changes from baseline to end-of-study or early termination.
Time frame: Baseline and end-of-study or early termination, up to approximately 7 weeks per participant
Change in NPI-NH occupational disruptiveness ratings
Occupational disruptiveness associated with participants' neuropsychiatric symptoms will be measured using the NPI-NH occupational disruptiveness ratings. Each applicable symptom domain is rated from 0 to 5, with higher ratings indicating greater occupational disruptiveness. Ratings will be summarized descriptively to explore change from baseline to end-of-study or early termination.
Time frame: Baseline and end-of-study or early termination, up to approximately 7 weeks per participant
Change in quality of life measured by the Quality of Life in Alzheimer's Disease scale, proxy version
Quality of life will be measured using the proxy-rated Quality of Life in Alzheimer's Disease scale (QoL-AD). The standard 13-item version is rated on a 4-point scale, with total scores ranging from 13 to 52. Higher scores indicate better perceived quality of life. Scores will be summarized descriptively to explore changes in proxy-rated quality of life from baseline to end-of-study or early termination.
Time frame: Baseline and end-of-study or early termination, up to approximately 7 weeks per participant
Change in clinician-rated global agitation severity measured by modified CGI-S agitation rating
Clinician-rated global agitation severity will be assessed using a study-specific modified Clinical Global Impression-Severity (CGI-S) agitation rating. The modified CGI-S agitation rating uses a 7-point scale, with higher scores indicating greater agitation severity. Scores will be summarized descriptively to explore change in global agitation severity from baseline to end-of-study or early termination.
Time frame: Baseline and end-of-study or early termination, up to approximately 7 weeks per participant
Descriptive patterns of medication use
Medication use will be summarized descriptively, including scheduled psychotropic medications, changes in scheduled psychotropic medications, PRN/as-needed medication use, PRN/rescue medication use for acute agitation or behavioural distress, and timing of PRN/rescue medication use relative to VR sessions. Medication data will not be used to direct clinical care and will not be interpreted as evidence of medication reduction efficacy.
Time frame: Baseline through end-of-study or early termination, up to approximately 7 weeks per participant
Plan to share: No — Individual participant data will not be shared. This is a small feasibility study involving a vulnerable inpatient population with dementia and clinically significant agitation. Because of the small sample size and the sensitive clinical, behavioural, medication, and care-context data collected, individual-level data may carry a risk of participant re-identification even after de-identification. Aggregate study findings may be shared through publications, presentations, or reports. Any future data sharing beyond aggregate results would require appropriate research ethics board and institutional approvals and, where applicable, a data-sharing agreement.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 835 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 875 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's →