- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04436783
Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo
Background and Rationale:
Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, affecting 2.4% of the general population and 30% of those over 70 years old. The main symptom is the perceived sensation of movement of the surrounding or self, without actual such movement, triggered by changes in position (positional vertigo). It can be dangerous as repetitive symptoms can lead to falls and depression, particularly in the elderly. Additionally, at least half of those with initial symptoms of BPPV will have ongoing symptoms if not treated. The Epley maneuver is a particle-repositioning maneuver that is used to treat posterior semicircular canal BPPV, the most common type of BPPV, after a diagnosis has been made on physical examination. In-office administration of the Epley maneuver by a specialist yields a 90% success rate at treating the condition; however, at-home administration is much less successful. In a previous paper we demonstrated the development and face validation of a Virtual Reality Epley Maneuver System (VREMS) for performing the Epley maneuver correctly. In this study we aim to apply VREMS treatment in patients who have been diagnosed with BPPV.
Research Question and Objectives:
PICO (Patient/Population Intervention Compare Outcome): In adult patients diagnosed with posterior canal BPPV by a specialist, does VREMS, as compared to self-performed Epley maneuver using an instructional handout (IH) result in improved or resolved symptoms?
Methods:
Vertigo patients referred to the Neurovestibular Clinic will be evaluated by an Ear, Nose and Throat (ENT) specialist. Those who are diagnosed with posterior canal BPPV after history and physical examination including the Dix-Hallpike test will be approached to be recruited into the study. Patients who consent to participating in the study will be allocated to either the VREMS cohort or the control cohort. Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted or based on reading the IH. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver. All patients will also be asked to complete the NASA Task Load Index (NASA-TLX) to gauge their perceived mental workload. They will also be given an opportunity to give free-text feedback. For any patient with residual BPPV symptoms following Epley maneuver with VREMS or IH, the ENT specialist/vestibular physiotherapist will perform the Epley maneuver to ensure resolution of symptoms if possible prior to discharge from the clinic. The primary outcome of the study will be the improvement in and resolution of BPPV symptoms with VREMS use as compared to IH. Secondary outcome will be mental workload in each of the study arms.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reza Tabanfar, MD
- Phone Number: 5879683027
- Email: rezatabanfar@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults (over 18 years old)
- Clinical diagnosis of posterior semicircular canal benign paroxysmal positional vertigo
Exclusion Criteria:
- Hemodynamically unstable
- Cervical spine instability
- Limited neck range of motion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Reality Epley Maneuver System - VREMS
Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment.
All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver.
Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted.
In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver
|
The VREMS system includes a smartphone placed inside virtual reality goggles worn by the participant.
On the smartphone there is a virtual reality application.
When viewed through the VR goggles the participants see a three-dimensional environment.
Audio and text cues are presented in a 3D environment to help guide the patient through the Epley maneuver.
|
Active Comparator: Instructional Handout (IH)
Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver.
They will be given a chance to review the IH, and then they will have a chance to perform the Epley maneuver.
|
Patients randomized to the IH group will be given an instructional handout with image and text-based instructions on the steps involved in performing the Epley maneuver.
They will then be given the chance to perform the Epley maneuver.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective dizziness
Time Frame: Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms
|
Patient reported dizziness score out of 10 - Min value 0(no dizziness) and max value 10 (completely debilitating dizziness).
The higher the score, the greater the subjective dizziness (worse outcome).
|
Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental demand
Time Frame: Reported once immediately before performing the Epley maneuver and once immediately after - in both arms
|
Mental demand reported using the National Aeronautics and Space Administration (NASA) - Task Load Index - Minimum score 0 (no mental demand) and maximum score is 100 (very high mental demand).
The higher the score, the greater the mental demand (worse outcome).
|
Reported once immediately before performing the Epley maneuver and once immediately after - in both arms
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Euna Hwang, MD, University of Calgary
Publications and helpful links
General Publications
- Hanley K, O'Dowd T, Considine N. A systematic review of vertigo in primary care. Br J Gen Pract. 2001 Aug;51(469):666-71.
- Kuo CH, Pang L, Chang R. Vertigo - part 1 - assessment in general practice. Aust Fam Physician. 2008 May;37(5):341-7.
- Strupp M, Brandt T. Diagnosis and treatment of vertigo and dizziness. Dtsch Arztebl Int. 2008 Mar;105(10):173-80. doi: 10.3238/arztebl.2008.0173. Epub 2008 Mar 7.
- von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
- Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8.
- Gopinath B, McMahon CM, Rochtchina E, Mitchell P. Dizziness and vertigo in an older population: the Blue Mountains prospective cross-sectional study. Clin Otolaryngol. 2009 Dec;34(6):552-6. doi: 10.1111/j.1749-4486.2009.02025.x.
- Neuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of dizziness and vertigo in the community. Arch Intern Med. 2008 Oct 27;168(19):2118-24. doi: 10.1001/archinte.168.19.2118. Erratum In: Arch Intern Med. 2009 Jan 12;169(1):89.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB19-1367
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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