Visual Feedback Goggle for Positional Vertigo Treatment

Vertigone

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Positional Vertigo; Vertigo

Treatments: Device: Goggle with 20 degree error; Device: Optimized Goggle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729885

V200601

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1 Goggle I

Experimental group

Description:

Optimized Goggle

Treatment:

Device: Optimized Goggle

2 Google II

Sham Comparator group

Description:

Goggle with 20 Degree error

Treatment:

Device: Goggle with 20 degree error