Recruiting

VR-Therapy

Sponsor:

University Health Network, Toronto

Code:

NCT05867641

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Immersive VR Therapy in Head-Mounted Display (HMD) (Solo)

Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)

Study Details

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).

Conditions

Dementia

Study ID

NCT05867641

Start date

Feb 12, 2025

Status verified date

Mar, 2025

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VR&R Therapy - Solo First

Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist.

For the first two weeks, only the caregiver will be present to use VR with the person with dementia. For the following two weeks, a research assistant will be present to use VR with the person with dementia.

experimental: VR&R Therapy - Social First

Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist.

For the first two weeks, a research assistant will be present to use VR with the person with dementia. For the following two weeks, only the caregiver will be present.

Interventions

Immersive VR Therapy in Head-Mounted Display (HMD) (Solo)

Caregivers will be trained to administer VR\&R therapy to their loved ones with dementia, in their private home/residence. Participants with dementia will view immersive VR experiences using a commercially-available VR head-mounted device for up to 30 minutes a time, approximately every other day (or as desired), for two weeks. The caregiver will use the custom application on a tablet to select and monitor what their loved one sees in VR.

Staying nearby to monitor for safety and assistance, the caregiver may choose to use the time when their loved one is engaged to take some respite time for themselves (e.g., make a cup of coffee, have an uninterrupted phone call).

Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)

Participants with dementia will view immersive VR experiences using a commercially-available VR head-mounted device for up to 30 minutes a time, 2 to 3 times per week, for 2 weeks. A research assistant who is trained in dementia care will use the custom application on a tablet to select and monitor what their loved one sees in VR.

Staying nearby to monitor for safety and assistance, the caregiver may choose to use the time when their loved one is engaged to take some respite time for themselves (e.g., make a cup of coffee, have an uninterrupted phone call).

Primary outcome measure

  • Change in Caregiver Respite and Burden [ Time Frame: 6 Weeks ]
  • Change in Caregiver Respite and Burden: Caregiver Phone Interview [ Time Frame: 6 Weeks ]
  • Change Caregiver Well-Being [ Time Frame: 6 Weeks ]
  • Change in Caregiver Respite and Burden: Post-Session Log [ Time Frame: 4 Weeks ]
  • Change in Caregiver Resilience [ Time Frame: 6 Weeks ]

Central Contacts and Locations

Central contacts

Lora Appel, PhD

6475046537lora.appel@yorku.ca

Lora Appel, PhD

lora.appel@uhn.ca

Locations

Acclaim Health

Recruiting

Oakville, Ontario, Canada, L6L 5M2

Contacts

Patricia Blakely

pblakeley@acclaimhealth.capblakeley@acclaimhealth.ca

Chester Village

Recruiting

Toronto, Ontario, Canada, M1L 1E3

Contacts

Cynthia Marianelli

416-466-2173cynthia@chestervillage.ca

Circle of Care

Recruiting

Toronto, Ontario, Canada, M2P 2A9

Contacts

Lisa Rae

416-635-2860lrae@circleofcare.com

Toronto Grace Hospital - Remote Care Monitoring

Recruiting

Toronto, Ontario, Canada, M4Y 2G5

Contacts

Danielle Lechman

437-233-2661dkilby-Lechman@torontograce.org

Toronto Grace Hospital - Specialized Care Centre

Recruiting

Toronto, Ontario, Canada, M4Y 2G5

Contacts

Chrincia Bernard

647-670-2611cbernard@torontograce.org

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 28, 2025

Last verified

Mar, 2025

Keywords

  • Non-pharmacological
  • Caregiver Respite
  • Virtual Reality
  • Home Based Care
  • Quality of Life
  • Behavioral and psychological symptoms of dementia
  • Mood
  • Well-Being
  • Serious Game

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-03-28.