Helpfulness of the Vibration Test Performed in Room Light on Clients With Inner Ear Problems

Overview

The purpose of this study is to explore the diagnostic values associated with both a positive and negative Skull Vibration Induced Nystagmus Test (SVINT) performed in room light (with fixation). The hypotheses include: 1. A positive room light SVINT will be identified in individuals with moderate to severe vestibular asymmetries. 2. A positive room light SVINT will be present when 10 beats or more (counted over 10 seconds) of nystagmus are found with fixation blocked.

Full Title of Study: “Diagnostic Accuracy of the Vibration Induced Nystagmus Test in Room Light.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 26, 2017

Detailed Description

Dizziness and vertigo account for about four million visits to the Emergency Department per year and costs for management in the Emergency Department are estimated to be about four billion dollars per year. Vestibular problems are a major cause of dizziness. Simple to perform and inexpensive bedside vestibular tests are needed. The Skull Vibration-Induced Nystagmus Test (SVINT) with fixation blocked has been considered a vestibular gold standard test with strong psychometric values. No studies on the diagnostic accuracy of the SVINT in room light have been performed.

Interventions

  • Behavioral: Dizziness Handicap Inventory
    • A standardized questionnaire used to quantify symptoms of dizziness.
  • Behavioral: Global Rating of Change
    • A standardized questionnaire used to review the overall outcome of the participants condition with physical therapy.
  • Behavioral: Patient Acceptable Symptom State
    • A standardized questionnaire used to determine whether meaningful progress has been made
  • Procedure: Spontaneous Nystagmus Test
    • An observational test procedure used to identify involuntary eye movements caused by inner ear and/or brain dysfunction. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.
  • Procedure: Gazehold Nystagmus Test
    • An observational test procedure used to identify involuntary eye movements caused by inner ear and/or brain dysfunction. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.
  • Procedure: Primary Vibration Test
    • A test used to identify asymmetry that may be present in the vestibular system through 60-100 MHz vibration applied to the mastoid bone. A WAHL massager is used to stimulate the inner ear by vibrating the mastoid bone. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.

Clinical Trial Outcome Measures

Primary Measures

  • Primary Vibration Test
    • Time Frame: Baseline
    • Under room light, the presence or absence of nystagmus is determined. If nystagmus is present, then the direction of nystagmus is determined. When fixation is blocked, the presence or absence of nystagmus is determined. If nystagmus is present, then the direction of nystagmus is determined. The number of beats per 10 sec is also determined.

Secondary Measures

  • Dizziness Handicap Inventory
    • Time Frame: Baseline; last day of physical therapy, an average of 4 weeks
    • Score on DHI.
  • Global Rating of Change
    • Time Frame: Baseline; last day of physical therapy, an average of 4 weeks
    • Score on Global Rating of Change
  • Patient Acceptable Symptom State
    • Time Frame: Baseline; last day of physical therapy, an average of 4 weeks
    • Yes or No response
  • Spontaneous Nystagmus Test
    • Time Frame: Baseline
    • Presence, intensity, and direction of nystagmus is determined
  • Gazehold Nystagmus Test
    • Time Frame: Baseline
    • Presence, intensity, and direction of nystagmus is determined

Participating in This Clinical Trial

Inclusion Criteria

  • Clients 18 years and older with complaint of dizziness, vertigo, and/or imbalance who are willing to proceed with procedures of study. – Inclusion for control group: no history of dizziness, vertigo, and/or imbalance. Exclusion Criteria:

  • Conditions that warrant immediate referral to the Emergency Department or Primary Care Physician (undiagnosed and unstable disorders relating to cardiac, neurologic, metabolic, etc, dysfunction); no history of dizziness, vertigo, and/or balance problems. – Clients with conditions that therapists believe may be aggravated by testing including, but not limited to: variants of head injuries, migraines, seizure disorders, panic/anxiety, claustrophobia, severe headache and/or nausea, and hypersensitivity to sensory stimuli

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Aultman Health Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andy Beltz, PT, Principal Investigator, Aultman Health Foundation

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.