Visual Feedback Goggle for Positional Vertigo Treatment | NCT00729885

Studies
Visual Feedback Goggle for Positional Vertigo Treatment

NCT00729885

Sponsor

Vertigone Inc.

Status

Unknown status

Last Update Posted

Aug 8, 2008Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Positional Vertigo
Vertigo

Interventions

Goggle with 20 degree error
Optimized Goggle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Aug 2008Estimated

Completion Date

Not provided

First Submitted Date

Aug 1, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2008

Last Update Posted Date

Aug 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 Goggle I	Experimental	Optimized Goggle	Device: Optimized Goggle
2 Google II	Sham Comparator	Goggle with 20 Degree error	Device: Goggle with 20 degree error

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Goggle with 20 degree error	Device	The Vertigone Goggle is modified such that the head positions and visual feedback indicators are offset 20° from the classic Epley positions.

Outcomes Module

Primary Outcomes

Measure	Description	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip F Anthony, MD	Vertigone Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jay Farrior, MD		Tampa	Florida		United States
Debra Cooke, PH.D.

References Module

Citations

Not provided

ID	Term
D015837	Vestibular Diseases
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D000067393	Personal Protective Equipment
D011482	Protective Devices
D004864	Equipment and Supplies
D008420	Manufactured Materials