Clinical trial NCT00729885: Visual Feedback Goggle for Positional Vertigo Treatment
Official title: Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Positional Vertigo
Vertigo
Keywords: Vertigo
Benign Paroxysmal Positional Vertigo
BPPV
Positional Vertigo
Lead sponsor: Vertigone Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptom Relief Speed (SRS): defined as the number of days post-treatment until dizziness symptoms improve to category 5 (70-100% improvement from baseline).
timeFrame: This endpoint will be measured twice: once following the baseline visit and again following the subsequent visit and treatment.
measure: Symptom Relief Completeness (SRC): defined as the highest level (on the ordinal scale) of improvement attained during the allotted seven-day time period.
timeFrame: This endpoint will also be measured twice, in the same manner as was SRS.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Jay Farrior, MD
state: Florida
city: Kansas City
country: United States
facility: Debra Cooke, PH.D.
state: Missouri
city: Nashville
country: United States
facility: Mitchell Schwaber, MD
state: Tennessee
Study officials:
affiliation: Vertigone Inc.
name: Philip F Anthony, MD
role: PRINCIPAL_INVESTIGATOR
References: