Visual Feedback Goggle for Positional Vertigo Treatment

Phase 1

• Conditions: Positional Vertigo; Vertigo
• Interventions: Device: Optimized Goggle; Device: Goggle with 20 degree error

• Registration Number: NCT00729885
• Lead Sponsor: Vertigone Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Status Verified: 2008-08
• Primary Completion: 2008-08
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-07
• Last Update Submitted: 2008-08-07
• Study First Posted: 2008-08-08
• Last Update Posted: 2008-08-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 Goggle I	Optimized Goggle	Optimized Goggle
2 Google II	Goggle with 20 degree error	Goggle with 20 Degree error

Primary Outcome Measures

Name	Time	Method
Symptom Relief Speed (SRS): defined as the number of days post-treatment until dizziness symptoms improve to category 5 (70-100% improvement from baseline).	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.	This endpoint will also be measured twice, in the same manner as was SRS.

Trial Locations

Locations (3)

Jay Farrior, MD; 🇺🇸 Tampa, Florida, United States

Debra Cooke, PH.D.; 🇺🇸 Kansas City, Missouri, United States

Mitchell Schwaber, MD; 🇺🇸 Nashville, Tennessee, United States