Visual Feedback Goggle for Positional Vertigo Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Vertigone Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vertigone Inc.
ClinicalTrials.gov Identifier:
NCT00729885
First received: August 1, 2008
Last updated: August 7, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Positional Vertigo
Vertigo
Device: Goggle with 20 degree error
Device: Optimized Goggle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study

Resource links provided by NLM:


Further study details as provided by Vertigone Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2006
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Additional Information:
No publications provided

Responsible Party: Philip F. Anthony, MD, Vertigone, Inc
ClinicalTrials.gov Identifier: NCT00729885     History of Changes
Other Study ID Numbers: V200601
Study First Received: August 1, 2008
Last Updated: August 7, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014