Vertigo Clinical Trial
Official title:
Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study
Benign Paroxysmal Positional Vertigo (BPPV) is one of the most common causes of vertigo and
the most common vestibular disorder of the inner ear. BPPV is the result of small
free-floating particles (canaliths) in the posterior semicircular canals where they
aggravate the sensory apparatus and induce sudden and severe attacks of vertigo when the
head is turned into certain positions.
The treatment of BPPV was revolutionized by the introduction of the Epley maneuver, a
sequence of head movements that use gravity to reposition the canaliths within the inner
ear. The Epley maneuver provides prompt relief from vertigo in approximately 80% of
patients.
The innovation, the Vertigone goggle, provides both physician and patient with visual
feedback to guide them through an accurate Epley maneuver. This changes the current
treatment paradigm for BPPV, greatly increasing the availability of the maneuver to
non-specialist physicians, nurse practitioners, physician's assistants and physical
therapists. The device is designed so that the patient with recurrent vertigo can use the
goggle to treat BPPV at home. The goggle is currently a pre-market prototype.
The hypothesis for the study is that accuracy in the performance of the Epley maneuver
correlates with improved clinical resolution of vertigo in BPPV patients. If the hypothesis
is true, then there is a clear case for the utility of the visual feedback provided by the
VertiGONE goggle in performing the maneuver.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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