Recruiting

Vestibular Therapy

Sponsor:

University of British Columbia

Code:

NCT05424302

Conditions

Peripheral Vestibular Disorder

Benign Paroxysmal Positional Vertigo

Meniere Disease

Vestibular Neuritis

Vestibular Neuronitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Standard Vestibular Rehabilitation with Adjunct At Home Virtual Reality Vestibular Rehabilitation

Standard Vestibular Rehabilitation with Adjunct Auditory Intervention

Study Details

Brief 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.

Conditions

Peripheral Vestibular Disorder

Benign Paroxysmal Positional Vertigo

Meniere Disease

Vestibular Neuritis

Vestibular Neuronitis

Study ID

NCT05424302

Start date

Jun 1, 2024

Status verified date

Aug, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality Group

Patients have baseline data collected two weeks pre-intervention by assessing patient symptomatology using the dizziness handicap inventory, activities specific balance confidence questionnaires and a simulator sickness questionnaire remotely. Next, an interview will be conducted to collect information including age, sex, ethnicity, physical activity level and VR experience. Lastly, VR headset will be mailed to patients home address. A date for VR device tutorial will be discussed during this interview. Next patients will undergo 4 or 8 weeks of vestibular rehabilitation if diagnosed with unilateral or bilateral vestibular hypofunction respectively. This involves weekly 40-45 minute in-person sessions with a physiotherapist and three 20 minute sessions a day of at-home independent exercises. In addition, they will undergo an at home VR vestibular rehabilitation protocol that involves playing a video game projected on an android or apple device in a VR headset for 20 minutes daily.

active comparator: Control Group

Patients have baseline data collected two weeks pre-intervention by assessing patient symptomatology using the dizziness handicap inventory, activities specific balance confidence questionnaires and a simulator sickness questionnaire remotely. Next, an interview will be conducted to collect information including age, sex, ethnicity, physical activity level and VR experience. Next patients will undergo 4 or 8 weeks of vestibular rehabilitation if diagnosed with unilateral or bilateral vestibular hypofunction respectively. This involves weekly 40-45 minute in-person sessions with a physiotherapist and three 20 minute sessions a day of at-home independent exercises. In addition, they will undergo an at-home regime that consists of auditory stimulation while wearing a VR headset for 20 minutes daily.

Interventions

Standard Vestibular Rehabilitation with Adjunct At Home Virtual Reality Vestibular Rehabilitation

The virtual reality intervention will involve standard vestibular rehabilitation as described above and adjunct at home virtual reality video game. This video game will be projected on an android or apple device accommodated into a VR headset for 20 minutes daily until the vestibular rehabilitation is complete. This video will be congruent to current vestibular rehabilitation program exercises. Point-of-view games compatible with both Android and iOS devices will be evaluated by professionals to determine the game that is most representative of current evidence based exercises.

Standard Vestibular Rehabilitation with Adjunct Auditory Intervention

The control intervention will involve standard vestibular rehabilitation as described above and adjunct audio intervention while wearing the VR headset for 20 minutes daily until the vestibular rehabilitation is complete.

Primary outcome measure

  • Dizziness Handicap Inventory (DHI) score [ Time Frame: Change from baseline DHI score at 2 weeks post-intervention will be recorded for each patient. ]

Central Contacts and Locations

Central contacts

Austin Heffernan, BMSc

604-875-4111aheff12@student.ubc.ca

Lindsay E Booth, BSc

604-875-4111lbooth98@student.ubc.ca

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6K2E8

Contacts

Austin Heffernan, MD

4165783035aheff12@student.ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Aug 15, 2024

Last verified

Aug, 2024

Keywords

  • Virtual reality
  • Video games
  • Peripheral vestibular disorders
  • Benign paroxysmal positional vertigo
  • Meniere disease
  • Vestibular Neuritis
  • Vestibular Neuronitis
  • Labyrinthitis
  • Herpes Zoster Oticus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-08-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.