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CompletedNCT02626052Updated Jan 18, 2020

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

An observational study in Vestibular Disease, sponsored by Aultman Health Foundation. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Aultman Health Foundation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
256
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Vestibular Disease

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Keywords

  • Skull vibration induced nystagmus test
  • mastoid vibration test
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In context

Vestibular Diseases

172 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.

This study's enrollment of 256 is above the median of 59 across 34 observational studies indexed under Vestibular Diseases.

Browse Vestibular Diseases studies →

Lead sponsor

Aultman Health Foundation is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with complaints of dizziness, vertigo, and/or imbalance referred to the hospital outpatient physical therapy department.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
256 participants (actual)
Patient registry
No

Interventions

  • BehavioralDizziness Handicap Inventory

    A standardized questionnaire used to quantify symptoms of dizziness.

  • BehavioralGlobal Rating of Change

    A standardized questionnaire used to review the overall outcome of the participants condition with physical therapy.

  • BehavioralPatient Acceptable Symptom State

    A standardized questionnaire used to determine whether meaningful progress has been made

  • ProcedureSpontaneous 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.

  • ProcedureGazehold 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.

  • ProcedurePrimary 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. Dizziness Handicap Inventory

    Score on DHI.

    Time frame: Baseline; last day of physical therapy, an average of 4 weeks

  2. Global Rating of Change

    Score on Global Rating of Change

    Time frame: Baseline; last day of physical therapy, an average of 4 weeks

  3. Patient Acceptable Symptom State

    Yes or No response

    Time frame: Baseline; last day of physical therapy, an average of 4 weeks

  4. Spontaneous Nystagmus Test

    Presence, intensity, and direction of nystagmus is determined

    Time frame: Baseline

  5. Gazehold Nystagmus Test

    Presence, intensity, and direction of nystagmus is determined

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02626052
Lead sponsor
Aultman Health Foundation
Responsible party
Sponsor
First posted
Dec 10, 2015
Start date
Dec 2015
Primary completion
Jan 26, 2017
Completion
Jan 26, 2017
Last update
Jan 18, 2020

Study contacts

Andy Beltz, PT
principal investigator · Aultman Health Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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