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VR Therapy for Dementia (VR&R Trial)
N/A
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates how immersive VR therapy can help individuals with dementia and their informal caregivers by providing quality respite time and reducing feelings of burden.
Who is the study for?
This trial is for people with dementia aged 65 or older living at home with a family caregiver who can access the internet. Caregivers should be able to speak and understand English, provide consent, and assist their loved one. Excluded are those with certain legal guardianships, language barriers, pacemakers, blindness, open facial wounds (except sutured lacerations), seizure history, recent head trauma or stroke, unsafe cervical conditions for VR use, or alcohol-related dementia.
What is being tested?
The study tests if immersive VR therapy helps caregivers get respite time and improves well-being while managing symptoms of dementia like mood swings and agitation in patients. It explores which type of VR content—passive videos, interactive games or cooperative experiences—is most effective over three weeks of sessions.
What are the potential side effects?
Potential side effects from using VR may include motion sickness or dizziness due to the immersive experience. There might also be discomfort wearing the headset especially for individuals with pre-existing conditions that affect the face or neck.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Caregiver Respite and Burden: Post-Session Log
Change in Caregiver Respite and Burden: Caregiver Phone Interview
Change in Caregiver Respite and Burden: Short Zarit Burden Interview
Secondary study objectives
Change in PwD Behavioural and Psychological Symptoms of Dementia: Apathy
Change in PwD Behavioural and Psychological Symptoms of Dementia: Depression
Change in PwD Behavioural and Psychological Symptoms of Dementia: Neuropsychiatric Symptoms
+3 moreOther study objectives
PwD Preferences/Reactions to VR
PwD Preferences/Reactions to VR: Head Movements in VR
PwD Preferences/Reactions to VR: Post Session Log
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VR&R TherapyExperimental Treatment1 Intervention
Recruited dyads will include one person diagnosed with dementia and their informal caregiver (i.e., 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.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,527 Previous Clinical Trials
503,516 Total Patients Enrolled
16 Trials studying Dementia
2,018 Patients Enrolled for Dementia
Centre for Aging and Brain Health InnovationOTHER
15 Previous Clinical Trials
5,170 Total Patients Enrolled
3 Trials studying Dementia
125 Patients Enrolled for Dementia
Ontario AHSC AFP Innovation FundUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am legally blind.I am a primary caregiver with internet access and a device for the study.I do not have any open wounds on my face, except for stitched cuts.I have a neck condition or injury that makes using VR headsets unsafe.I am a caregiver unable to give informed consent due to cognitive reasons.I am a primary caregiver and I am legally blind.I am 65 or older with dementia.I have dementia and live at home with a family member who cares for me.My primary caregiver does not speak or understand English.
Research Study Groups:
This trial has the following groups:- Group 1: VR&R Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.