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

Vestibular Disease Clinical Trial

Official title:

Diagnostic Accuracy of the Vibration Induced Nystagmus Test in Room Light.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626052
• Other study ID #: 2015.11.19.F1
• Status: Completed
• Start date: December 2015
• Est. completion date: January 26, 2017

Study information

• Verified date: January 2020
• Source: Aultman Health Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: January 26, 2017
• Est. primary completion date: January 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Disease
• Vestibular Diseases

Intervention

Behavioral:
• Dizziness Handicap Inventory
A standardized questionnaire used to quantify symptoms of dizziness.
• Global Rating of Change
A standardized questionnaire used to review the overall outcome of the participants condition with physical therapy.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aultman Health Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Vibration Test	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.	Baseline
Secondary	Dizziness Handicap Inventory	Score on DHI.	Baseline; last day of physical therapy, an average of 4 weeks
Secondary	Global Rating of Change	Score on Global Rating of Change	Baseline; last day of physical therapy, an average of 4 weeks
Secondary	Patient Acceptable Symptom State	Yes or No response	Baseline; last day of physical therapy, an average of 4 weeks
Secondary	Spontaneous Nystagmus Test	Presence, intensity, and direction of nystagmus is determined	Baseline
Secondary	Gazehold Nystagmus Test	Presence, intensity, and direction of nystagmus is determined	Baseline