Clinical trial NCT02626052: Helpfulness of the Vibration Test Performed in Room Light on Clients With Inner Ear Problems
Official title: Diagnostic Accuracy of the Vibration Induced Nystagmus Test in Room Light.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vestibular Disease
Keywords: Skull vibration induced nystagmus test
mastoid vibration test
Lead sponsor: Aultman Health Foundation
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complaints of dizziness, vertigo, and/or imbalance referred to the hospital outpatient physical therapy department.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Vibration Test
timeFrame: Baseline
Secondary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: Baseline; last day of physical therapy, an average of 4 weeks
measure: Global Rating of Change
timeFrame: Baseline; last day of physical therapy, an average of 4 weeks
measure: Patient Acceptable Symptom State
timeFrame: Baseline; last day of physical therapy, an average of 4 weeks
measure: Spontaneous Nystagmus Test
timeFrame: Baseline
measure: Gazehold Nystagmus Test
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Aultman Health Foundation
name: Andy Beltz, PT
role: PRINCIPAL_INVESTIGATOR
References: