Clinical trial NCT04436783: Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo
Official title: Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BPPV
Vertigo, Peripheral
Keywords: BPPV
Vertigo
Peripheral vestibular disorder
Virtual reality
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjective dizziness
timeFrame: Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms
Secondary outcomes:
measure: Mental demand
timeFrame: Reported once immediately before performing the Epley maneuver and once immediately after - in both arms
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Euna Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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