Visual Feedback Goggle for Positional Vertigo Treatment
|ClinicalTrials.gov Identifier: NCT00729885|
Recruitment Status : Unknown
Verified August 2008 by Vertigone Inc..
Recruitment status was: Active, not recruiting
First Posted : August 8, 2008
Last Update Posted : August 8, 2008
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 or disease||Intervention/treatment||Phase|
|Positional Vertigo Vertigo||Device: Goggle with 20 degree error Device: Optimized Goggle||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||August 2008|
Experimental: 1 Goggle I
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.
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.
- 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. ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729885
|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.|