NCT05867641 VR&R: Providing Caregiver Respite by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy
| NCT ID | NCT05867641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-12 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-02-12 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this interventional trial is to learn about how immersive Virtual Reality (VR) therapy can be used at home by individuals with dementia, with assistance from their informal (e.g., friend/family) caregivers. The main question it aims to answer are: 1. Can caregivers receive quality respite time by using VR-therapy at home with their loved ones with dementia? Does this intervention reduce feelings of burden and improve well-being and resilience for caregivers? 2. Does VR-therapy help to manage behavioural and psychological symptoms (e.g., mood, apathy, agitation) and improve quality of life for individuals with dementia? 3. What types of VR "medium" (passive or cooperative) are most effective for achieving the above objectives? Participant pairs will be asked to: * Take part in an initial at-home VR technology training session and complete a series of brief questionnaires (e.g., health history/technology use, well-being/quality of life, symptoms of dementia) * Use "VR\&R" (VR Rest \& Relaxation Therapy) for a period of 4 weeks (30 minute sessions, desired frequency), and answer a brief set of questions after each VR\&R session * Provide feedback on the VR\&R intervention in semi-structured interview with the researcher and answer additional questionnaires at a 2-week follow-up During VR\&R sessions, participants with dementia will have the opportunity to choose to watch (1) immersive 360-degree videos (e.g., of a live performance, or beach) on their own and (2) experience the same VR videos together with a researcher. Caregivers will be asked to assist their loved one with dementia to use VR\&R by helping to put on the VR headset, selecting a VR experience through a user-friendly application, and remaining nearby to supervise and provide assistance as needed. During VR\&R sessions, caregivers may use this time to take a personal break or complete short tasks (e.g., make a cup of coffee, have an uninterrupted phone call).
Eligibility Criteria
Inclusion Criteria: People with dementia * Individuals who are 65 years of age or older * Individuals living at home with a family caregiver * Individuals diagnosed with dementia Exclusion Criteria: * Individuals with open wounds on face (sutured lacerations exempted) * Individuals with a history of seizures or epilepsy * Individuals with a pacemaker * Individuals with head trauma or stroke leading to their current admission * Individuals with cervical conditions or injuries that would make it unsafe for them to use the VR headset * Individuals who identify as being legally blind * Individuals with alcohol related dementia/ Korsakoff syndrome. * Individuals who have a Public Guardian and Trustee (PGT) as Substitute Decision Maker (SDM) * Individuals who cannot speak and understand English Caregiver inclusion criteria: * Individuals who identify as a primary caregiver for the PwD * Individuals who have access to the internet through a device (computer, tablet, or mobile phone) that can be used during the study Caregiver exclusion criteria: * Individuals who cannot speak and understand English * Individuals who are cognitively unable to provide informed consent for themselves * Identify as legally blind
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05867641 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05867641 currently recruiting?
Yes, NCT05867641 is actively recruiting participants. Contact the research team at lora.appel@yorku.ca for enrollment information.
Where is the NCT05867641 trial being conducted?
This trial is being conducted at Oakville, Canada, Toronto, Canada, Toronto, Canada, Toronto, Canada and 3 additional locations.
Who is sponsoring the NCT05867641 clinical trial?
NCT05867641 is sponsored by University Health Network, Toronto. The trial plans to enroll 50 participants.