Visual Feedback Goggle for Positional Vertigo Treatment
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
Positional Vertigo Vertigo |
Device: Goggle with 20 degree error Device: Optimized Goggle |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study |
- Symptom Relief Speed (SRS): defined as the number of days post-treatment until dizziness symptoms improve to category 5 (70-100% improvement from baseline). [ Time Frame: This endpoint will be measured twice: once following the baseline visit and again following the subsequent visit and treatment. ] [ Designated as safety issue: No ]
- Symptom Relief Completeness (SRC): defined as the highest level (on the ordinal scale) of improvement attained during the allotted seven-day time period. [ Time Frame: This endpoint will also be measured twice, in the same manner as was SRS. ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1 Goggle I
Optimized Goggle
|
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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Sham Comparator: 2 Google II
Goggle with 20 Degree error
|
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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Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 30-80
- 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:
- Age < 30 or Age > 80
- 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
Contacts and Locations| 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. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip F. Anthony, MD, Vertigone, Inc |
| ClinicalTrials.gov Identifier: | NCT00729885 History of Changes |
| Other Study ID Numbers: | V200601 |
| Study First Received: | August 1, 2008 |
| Last Updated: | August 7, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vertigone Inc.:
|
Vertigo Benign Paroxysmal Positional Vertigo BPPV Positional Vertigo |
Additional relevant MeSH terms:
|
Vertigo Dizziness Vestibular Diseases Labyrinth Diseases Ear Diseases |
Otorhinolaryngologic Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms Sensation Disorders |
ClinicalTrials.gov processed this record on May 16, 2013