NCT02626052

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2017

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

December 1, 2015

Last Update Submit

January 14, 2020

Conditions

Keywords

Skull vibration induced nystagmus testmastoid vibration test

Outcome Measures

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.

    Baseline

Secondary Outcomes (5)

  • Dizziness Handicap Inventory

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

  • Global Rating of Change

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

  • Patient Acceptable Symptom State

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

  • Spontaneous Nystagmus Test

    Baseline

  • Gazehold Nystagmus Test

    Baseline

Interventions

A standardized questionnaire used to quantify symptoms of dizziness.

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

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

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.

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clients 18 years and older with complaint of dizziness, vertigo, and/or imbalance who are willing to proceed with procedures of study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Andy Beltz, PT

    Aultman Health Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 10, 2015

Study Start

December 1, 2015

Primary Completion

January 26, 2017

Study Completion

January 26, 2017

Last Updated

January 18, 2020

Record last verified: 2020-01