Visual Feedback Goggle for Positional Vertigo Treatment
NCT ID: NCT00729885
Last Updated: 2008-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2006-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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1 Goggle I
Optimized Goggle
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.
2 Google II
Goggle with 20 Degree error
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Old patients (more than one year since first symptom)or new patients(more than 3 months duration of symptoms) diagnosed by physicians with Benign Paroxysmal Positional Vertigo (BPPV)
* Must have good neck flexibility to perform the movements of the Epley maneuver
* Subject is willing and able to provide written informed consent
* Subject is willing to remain in the clinic for the treatment and follow-up visits
Exclusion Criteria
* Can not perform the movements of the Epley maneuver
* No informed consent form
* Not willing to remain in the clinic for the treatment and follow-up visits
30 Years
80 Years
ALL
No
Sponsors
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Vertigone Inc.
INDUSTRY
Responsible Party
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Vertigone, Inc
Principal Investigators
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Philip F Anthony, MD
Role: PRINCIPAL_INVESTIGATOR
Vertigone Inc.
Locations
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Jay Farrior, MD
Tampa, Florida, United States
Debra Cooke, PH.D.
Kansas City, Missouri, United States
Mitchell Schwaber, MD
Nashville, Tennessee, United States
Countries
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Related Links
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Vertigone, Inc. 901 Hemphill Street, Fort Worth, Texas 76104
Other Identifiers
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V200601
Identifier Type: -
Identifier Source: org_study_id