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Visual Feedback Goggle for Positional Vertigo Treatment

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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
Sponsor:
Information provided by:
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.


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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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. ]
  2. 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. ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729885


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
Sponsors and Collaborators
Vertigone Inc.
Investigators
Principal Investigator: Philip F Anthony, MD Vertigone Inc.

Additional Information:
Responsible Party: Philip F. Anthony, MD, Vertigone, Inc
ClinicalTrials.gov Identifier: NCT00729885     History of Changes
Other Study ID Numbers: V200601
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: August 2008

Keywords provided by Vertigone Inc.:
Vertigo
Benign Paroxysmal Positional Vertigo
BPPV
Positional Vertigo

Additional relevant MeSH terms:
Vertigo
Dizziness
Benign Paroxysmal Positional Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders