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OpenTrials
Completed

NCT Number: NCT02626052

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dizziness Handicap Inventory

Behavioral

A standardized questionnaire used to quantify symptoms of dizziness.

Global Rating of Change

Behavioral

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

Patient Acceptable Symptom State

Behavioral

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

Spontaneous Nystagmus Test

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. 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 outcomes

  1. Dizziness Handicap Inventory

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

    Score on DHI.

  2. Global Rating of Change

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

    Score on Global Rating of Change

  3. Patient Acceptable Symptom State

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

    Yes or No response

  4. Spontaneous Nystagmus Test

    Time frame: Baseline

    Presence, intensity, and direction of nystagmus is determined

  5. Gazehold Nystagmus Test

    Time frame: Baseline

    Presence, intensity, and direction of nystagmus is determined

Sponsors and collaborators

Lead sponsor

Aultman Health Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 10, 2015
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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