Visual Feedback Goggle for Positional Vertigo Treatment

Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study

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.

Study Overview

• Status: Unknown
• Conditions: Vertigo; Positional Vertigo
• Intervention / Treatment: Device: Optimized Goggle; Device: Goggle with 20 degree error

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States
      • Jay Farrior, MD
  • Missouri
    • Kansas City, Missouri, United States
      • Debra Cooke, PH.D.
  • Tennessee
    • Nashville, Tennessee, United States
      • Mitchell Schwaber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Vertigone Inc.
• Investigators: Principal Investigator: Philip F Anthony, MD, Vertigone Inc.

Publications and helpful links

Helpful Links

• Vertigone, Inc. 901 Hemphill Street, Fort Worth, Texas 76104

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Anticipated): August 1, 2008

Study Registration Dates

• First Submitted: August 1, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Estimate): August 8, 2008
• Last Update Submitted That Met QC Criteria: August 7, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Benign Paroxysmal Positional Vertigo; Vertigo; BPPV; Positional Vertigo
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: V200601