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Sponsored by: |
Vertigone Inc. |
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Information provided by: | Vertigone Inc. |
ClinicalTrials.gov Identifier: | NCT00729885 |
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.
Condition | Intervention | Phase |
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Positional Vertigo Vertigo |
Device: Goggle with 20 degree error Device: Optimized Goggle |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Crossover Assignment, Efficacy Study |
Official Title: | Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study |
Estimated Enrollment: | 60 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Goggle I: Experimental
Optimized Goggle
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Device: Optimized Goggle
The classic Epley maneuver involves 3 head positions: 1) the patient supine, the neck is extended 20°and the head turned 45° towards the affected ear, 2) the patient rotates his head 90° to the contralateral side, with the final head position 45° from vertical, 3) the patient turns his head 135° towards the floor on the contralateral side. For the classic Epley maneuver, the goggle coach ball markings will be set for correct positioning.
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2 Google II: Sham Comparator
Goggle with 20 Degree error
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Device: Goggle with 20 degree error
The Vertigone Goggle is modified such that the head positions and visual feedback indicators are offset 20° from the classic Epley positions.
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Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Jay Farrior, MD | |
Tampa, Florida, United States | |
United States, Missouri | |
Debra Cooke, PH.D. | |
Kansas City, Missouri, United States | |
United States, Tennessee | |
Mitchell Schwaber, MD | |
Nashville, Tennessee, United States |
Principal Investigator: | Philip F Anthony, MD | Vertigone Inc. |
Responsible Party: | Vertigone, Inc ( Philip F. Anthony, MD ) |
Study ID Numbers: | V200601 |
Study First Received: | August 1, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00729885 |
Health Authority: | United States: Institutional Review Board |
Vertigo Benign Paroxysmal Positional Vertigo BPPV Positional Vertigo |
Signs and Symptoms Benign paroxysmal positional vertigo Otorhinolaryngologic Diseases Neurologic Manifestations |
Vestibular Diseases Ear Diseases Vertigo |
Nervous System Diseases Labyrinth Diseases |