Effect of Peripheral Vestibular Disease Location on Outcomes Following Home-based Virtual Reality… (NCT05424302) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Peripheral Vestibular Disease Location on Outcomes Following Home-based Virtual Reality Vestibular Therapy
Canada50 participantsStarted 2024-06-01
Plain-language summary
This parallel-group randomized controlled trial aims to determine if the location of the lesion(s) in the vestibular system (unilateral versus bilateral, lateral semi-circular canal versus otolith) impacts the effectiveness of adjunct take-home head-mounted display (HMD) virtual reality (VR) therapy in improving patient symptomatology. Fifty patients meeting inclusion criteria will be recruited from the principal investigator's neurotology clinic. Baseline symptomatology questionnaires will be completed, followed by random allocation to virtual reality and control groups. Vestibular rehabilitation and virtual reality protocols will be adhered to for 4 to 8 weeks, followed by symptomatology questionnaires. Data analysis will be conducted to answer the study's objectives.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants diagnosed with chronic (≥3 months) unilateral or bilateral peripheral vestibular disorders such as vestibular neuritis, labyrinthitis, Ramsay Hunt syndrome, ischemic lesion and trauma.
* Diagnosis made using caloric testing (≥25% reduced vestibular response) and either ocular vestibular evoked myogenic potential (oVEMP) or cervical vestibular evoked myogenic potential (cVEMP) testing.
* Participants prescribed vestibular rehabilitation
* Participants ≥18 years of age
* Access to an android or iOS smart phone
Exclusion Criteria:
* Pregnant participants
* Participant diagnosed with a central vestibular disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dizziness Handicap Inventory (DHI) score
Timeframe: Change from baseline DHI score at 2 weeks post-intervention will be recorded for each patient.