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NCT07893678
Virtual Reality to Advance Dementia Care and Quality of Life
Conditions: Dementia, Agitation, Behavioural and Psychological Symptoms of Dementia, Major Neurocognitive Disorder, Agitation Aggression in Dementia
Sex: All
Ages: 55 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Location: LHSC Victoria Hospital London Ontario
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Adults aged 55 years or older.
2. Diagnosis of Major Neurocognitive Disorder due to Alzheimer's disease or mixed/multiple etiologies (e.g., Alzheimer's disease with vascular contributions), based on DSM-5-TR criteria and documented clinical diagnosis.
3. Moderate-to-severe dementia, based on documented clinical diagnosis, clinical assessment, or available medical record information.
4. 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:
* demonstrate excessive motor activity, verbal aggression, and/or physical aggression associated with observed or inferred evidence of emotional distress;
* have behaviours that have been persistent or frequently recurrent for at least two weeks, or that represent a dramatic change from the prospective participant's usual behaviour;
* have behaviours that are severe and associated with excess distress or produce excess disability beyond that attributable to the cognitive impairment, including significant impairment in interpersonal relationships, other aspects of social functioning, or the ability to perform or participate in activities of daily living; and
* have agitation that is not attributable solely to another psychiatric disorder, medical condition-including delirium-suboptimal care conditions, or the physiological effects of a substance or medication.
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.
5. Admitted to one of the participating inpatient geriatric psychiatry units and considered by the treating team to be clinically appropriate for participation in a brief, seated, supervised VR intervention.
6. Expected by the treating team to remain admitted long enough to participate in at least some study procedures. Participants with uncertain discharge timing may still be considered eligible, and early discharge will be documented as part of feasibility and participant disposition outcomes.
7. Availability of a Substitute Decision-Maker (SDM) able to provide informed consent, when the participant is not capable of providing consent.
8. Participant able to provide assent when feasible or demonstrate behavioural willingness to participate, as assessed by the clinical and/or research team. Participants who verbally or non-verbally refuse participation, or who demonstrate distress or unwillingness, will not proceed with study procedures unless willingness is later re-established.
9. Availability of an appropriate respondent or information source, such as clinical staff familiar with the participant, SDM, family member, or care partner, to support completion of study assessments when required.
Exclusion Criteria:
1. Severe visual impairment that would prevent safe or meaningful engagement with the VR headset.
2. Active delirium at screening.
3. Clinically significant delusions and/or hallucinations that may increase the risk of distress during VR exposure, including NPI-NH delusion and/or hallucination subscale score ≥4, or clinical equivalent based on treating team assessment.
4. Uncontrolled seizure disorder.
5. Major psychotropic medication change within 7 days prior to enrollment that, in the opinion of the investigator or treating team, would substantially confound baseline agitation assessment or make participation clinically inappropriate.
6. Any medical, psychiatric, behavioural, sensory, or safety-related condition that, in the opinion of the treating team or study investigators, would make participation unsafe or not clinically appropriate.
Source: ClinicalTrials.gov (NCT07893678). StuddyBuddy aggregates publicly available trial information.