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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.

Tracking Information
First Submitted Date  ICMJE August 1, 2008
First Posted Date  ICMJE August 8, 2008
Last Update Posted Date August 8, 2008
Study Start Date  ICMJE November 2006
Estimated Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visual Feedback Goggle for Positional Vertigo Treatment
Official Title  ICMJE Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Positional Vertigo
  • Vertigo
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 1 Goggle I
    Optimized Goggle
    Intervention: Device: Optimized Goggle
  • Sham Comparator: 2 Google II
    Goggle with 20 Degree error
    Intervention: Device: Goggle with 20 degree error
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 7, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00729885
Other Study ID Numbers  ICMJE V200601
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philip F. Anthony, MD, Vertigone, Inc
Study Sponsor  ICMJE Vertigone Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip F Anthony, MD Vertigone Inc.
PRS Account Vertigone Inc.
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP