Visual Feedback Goggle for Positional Vertigo Treatment

Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00729885
• Other study ID #: V200601
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: August 1, 2008
• Last updated: August 7, 2008
• Start date: November 2006

Study information

• Verified date: August 2008
• Source: Vertigone Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness
• Positional Vertigo
• Vertigo

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vertigone Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No