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

• ClinicalTrials.gov Identifier: NCT02626052
• Recruitment Status: Completed
• First Posted: December 10, 2015
• Last Update Posted: January 18, 2020
• Sponsor: Aultman Health Foundation
• Information provided by (Responsible Party): Aultman Health Foundation

Study Description

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.

Condition or disease	Intervention/treatment
Vestibular Disease	Behavioral: Dizziness Handicap Inventory; Behavioral: Global Rating of Change; Behavioral: Patient Acceptable Symptom State; Procedure: Spontaneous Nystagmus Test; Procedure: Gazehold Nystagmus Test; Procedure: Primary Vibration Test

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 256 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diagnostic Accuracy of the Vibration Induced Nystagmus Test in Room Light.
• Study Start Date: December 2015
• Actual Primary Completion Date: January 26, 2017
• Actual Study Completion Date: January 26, 2017

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: 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.

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

Contacts and Locations

Sponsors and Collaborators

Aultman Health Foundation

Investigators

• Principal Investigator: Andy Beltz, PT; Aultman Health Foundation

More Information

• Responsible Party: Aultman Health Foundation
• ClinicalTrials.gov Identifier: NCT02626052
• Other Study ID Numbers: 2015.11.19.F1
• First Posted: December 10, 2015
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Keywords provided by Aultman Health Foundation:

Skull vibration induced nystagmus test; mastoid vibration test

Additional relevant MeSH terms:

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases