Vestibular DiseaseNCT02626052
Helpfulness of the Vibration Test Performed in Room Light on Clients With Inner Ear Problems
An observational study of Vestibular Disease, run by Aultman Health Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disease
- What is being tested?
- Dizziness Handicap Inventory, Global Rating of Change and Patient Acceptable Symptom State
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 26 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with complaints of dizziness, vertigo, and/or imbalance referred to the hospital outpatient physical therapy department.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Diagnostic Accuracy of the Vibration Induced Nystagmus Test in Room Light.
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.
- Conditions
- Vestibular Disease
- Being tested
- Dizziness Handicap Inventory, Global Rating of Change, Patient Acceptable Symptom State, Spontaneous Nystagmus Test, Gazehold Nystagmus Test
- Keywords
- Skull vibration induced nystagmus test, mastoid vibration test
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dizziness Handicap InventoryBehavioural
A standardized questionnaire used to quantify symptoms of dizziness.
Global Rating of ChangeBehavioural
A standardized questionnaire used to review the overall outcome of the participants condition with physical therapy.
Patient Acceptable Symptom StateBehavioural
A standardized questionnaire used to determine whether meaningful progress has been made
Spontaneous Nystagmus TestProcedure or surgery
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 TestProcedure or surgery
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 TestProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
Dizziness Handicap Inventory
Score on DHI.
Measured: Baseline; last day of physical therapy, an average of 4 weeks
Global Rating of Change
Score on Global Rating of Change
Measured: Baseline; last day of physical therapy, an average of 4 weeks
Patient Acceptable Symptom State
Yes or No response
Measured: Baseline; last day of physical therapy, an average of 4 weeks
Spontaneous Nystagmus Test
Presence, intensity, and direction of nystagmus is determined
Measured: Baseline
Gazehold Nystagmus Test
Presence, intensity, and direction of nystagmus is determined
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion26 Jan 2017
- Study completion26 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aultman Health Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andy Beltz, PT, Principal investigator, Aultman Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626052
- Sponsor's protocol ID
- 2015.11.19.F1
- Status last verified
- Jan 2020
- First submitted
- 1 Dec 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the Vibration Induced Nystagmus Test in Room Light.
- ClinicalTrials.gov ID
- NCT02626052
- Acronym / sponsor ID
- 2015.11.19.F1
- Conditions
- Vestibular Disease
- Keywords
- Skull vibration induced nystagmus test, mastoid vibration test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Aultman Health FoundationUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with complaints of dizziness, vertigo, and/or imbalance referred to the hospital outpatient physical therapy department.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dizziness Handicap InventoryA standardized questionnaire used to quantify symptoms of dizziness. | Behavioural | – |
| Global Rating of ChangeA standardized questionnaire used to review the overall outcome of the participants condition with physical therapy. | Behavioural | – |
| Patient Acceptable Symptom StateA standardized questionnaire used to determine whether meaningful progress has been made | Behavioural | – |
| Spontaneous Nystagmus TestAn 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 or surgery | – |
| Gazehold Nystagmus TestAn 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 or surgery | – |
| Primary Vibration TestA 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. | Procedure or surgery | – |
Primary outcome
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.
5 secondary outcomes
Dizziness Handicap Inventory
Time frame: Baseline; last day of physical therapy, an average of 4 weeks
Global Rating of Change
Time frame: Baseline; last day of physical therapy, an average of 4 weeks
Patient Acceptable Symptom State
Time frame: Baseline; last day of physical therapy, an average of 4 weeks
Spontaneous Nystagmus Test
Time frame: Baseline
Gazehold Nystagmus Test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Related trials for Vestibular Disease
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Beltz, PT principal investigator
Aultman Health Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Disease, run by Aultman Health Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Vibration Test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.