Overview

This trial is active, not recruiting.

Conditions positional vertigo, vertigo
Treatments goggle with 20 degree error, optimized goggle
Phase phase 1/phase 2
Sponsor Vertigone Inc.
Start date November 2006
End date August 2008
Trial size 60 participants
Trial identifier NCT00729885, V200601

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Optimized Goggle
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)
Goggle with 20 Degree error
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.

Primary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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

Additional Information

Official title Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study
Principal investigator Philip F Anthony, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by Vertigone Inc..