Normal Values in Hearing and Balance Testing
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 5 - 80 |
| Updated: | 3/27/2019 |
| Start Date: | September 21, 2012 |
| Contact: | Carmen C Brewer, Ph.D. |
| Email: | brewerc@nidcd.nih.gov |
| Phone: | (301) 496-5294 |
Normative Values in Audiovestibular Testing
Background:
- Researchers at the National Institutes of Health give many tests of hearing and balance.
These tests can help detect problems that affect hearing or balance. It is important to know
exactly how healthy people perform on each of these tests. This information will indicate
when a test result is normal and when a test result shows a problem. Researchers also want to
determine the best methods for each test.
Objectives:
- To test different types of hearing and balance tests, and collect information on normal
values for each test.
Eligibility:
- Healthy volunteers between 5 and 70 years of age.
Design:
- This study will require a single visit to the National Institutes of Health Clinical
Center. It will include both screening tests and study tests of hearing and balance.
Sometimes, a second visit may be required if a test is designed to measure the same
thing on 2 different days. Each visit will last between 2 and 5 hours, depending on the
number of tests scheduled per visit.
- Participants will have a physical exam and medical history. They will also have basic
tests to check for normal hearing and balance.
- Participants may have different hearing tests, including the following:
- Auditory Evoked Potentials to study how the ears and brain handle sound information.
- Auditory Processing Tests to study how a person processes complex sounds like speech in
background noise.
- Tests of middle ear and inner ear function.
- Participants may have different balance and inner ear tests, including the following:
- Balance test on a tilting platform.
- Different tests to measure how well the eyes, ears, and brain work together to help
maintain balance.
- Treatment will not be needed as part of this study.
- Researchers at the National Institutes of Health give many tests of hearing and balance.
These tests can help detect problems that affect hearing or balance. It is important to know
exactly how healthy people perform on each of these tests. This information will indicate
when a test result is normal and when a test result shows a problem. Researchers also want to
determine the best methods for each test.
Objectives:
- To test different types of hearing and balance tests, and collect information on normal
values for each test.
Eligibility:
- Healthy volunteers between 5 and 70 years of age.
Design:
- This study will require a single visit to the National Institutes of Health Clinical
Center. It will include both screening tests and study tests of hearing and balance.
Sometimes, a second visit may be required if a test is designed to measure the same
thing on 2 different days. Each visit will last between 2 and 5 hours, depending on the
number of tests scheduled per visit.
- Participants will have a physical exam and medical history. They will also have basic
tests to check for normal hearing and balance.
- Participants may have different hearing tests, including the following:
- Auditory Evoked Potentials to study how the ears and brain handle sound information.
- Auditory Processing Tests to study how a person processes complex sounds like speech in
background noise.
- Tests of middle ear and inner ear function.
- Participants may have different balance and inner ear tests, including the following:
- Balance test on a tilting platform.
- Different tests to measure how well the eyes, ears, and brain work together to help
maintain balance.
- Treatment will not be needed as part of this study.
Objective:
This is a normative data collection protocol. The primary objective is to establish the
normative range of data for the NIH research population on tests of auditory and vestibular
function that employ parameters and/or methodologies that are either new or unique to the
NIH, have been upgraded (software and/or hardware), or have not been well standardized in the
literature. Use of the normative data will be two-fold: 1) it will serve as a reference
interval of normal performance by which test results can be interpreted as normal or abnormal
and, in some cases 2) it will be used as control data for the purpose of comparison to data
obtained in various patient groups.
Secondary objectives, when applicable, are to evaluate: 1) the effect of a change in
methodology, stimulus characteristics, test equipment, or test paradigm on normative data for
existing measures, 2) the influence of subject age and gender on normative data, and 3)
intra-subject variability on repeated measures.
This protocol provides the construct for small, targeted normative studies and, subsequently,
there are no specific a priori hypotheses.
Study population:
Healthy volunteers ranging in age from 5-80 years will be studied under this protocol.
Design:
This protocol is designed to collect normative data on tests of audiometric and vestibular
function. Small sub-studies will be conducted on healthy volunteers in order to determine the
normal distribution of performance on defined subsets of hearing and/or balance tests. These
sub-studies will fall into one of the following five general categories: serial monitoring of
auditory function, auditory evoked potentials, auditory processing, middle ear function, and
vestibular function. All participants will have a basic hearing test and tympanometry to
confirm eligibility for the protocol. The subsequent measures of auditory or vestibular
function will depend on the defined subset of tests for which normative data is being sought.
Possible tests for normal data collection would include: middle ear function tests (MEF),
otoacoustic emissions (OAE), auditory evoked potentials (AEP), tests of auditory processing
(AP), computerized dynamic platform posturography (CDPP), vestibular evoked myogenic
potentials (VEMP), videonystagmography (VNG) and/or rotational vestibular testing (RVT).
The selection of tests for each sub-study will be determined either by the need to establish
control data for a patient population currently being evaluated under a collaborative
protocol, or to establish normative data on a test that will further expand our ability to
investigate specific pathology/function for which no equivalent published normative data are
available (e.g., otolith disease, auditory processing disorders). The specific tests that
each participant will perform will be clearly indicated and described in the consent/assent
documents and will be explained during the consent/assent process. Testing will be conducted
during a single outpatient clinic visit with the exception of measures for which test-retest
reliability is being investigated.
Outcome measures:
This is a normative data collection protocol designed to describe normal behavioral and
physiologic auditory and vestibular function for the NIH research population. Outcome
measures will vary from test to test and include one or more of the following: 1) response
threshold, amplitude, latency, velocity, frequency response, and/or accuracy, 2) number
and/or percent correct, 3) response repeatability, and 4) interaural response differences.
This is a normative data collection protocol. The primary objective is to establish the
normative range of data for the NIH research population on tests of auditory and vestibular
function that employ parameters and/or methodologies that are either new or unique to the
NIH, have been upgraded (software and/or hardware), or have not been well standardized in the
literature. Use of the normative data will be two-fold: 1) it will serve as a reference
interval of normal performance by which test results can be interpreted as normal or abnormal
and, in some cases 2) it will be used as control data for the purpose of comparison to data
obtained in various patient groups.
Secondary objectives, when applicable, are to evaluate: 1) the effect of a change in
methodology, stimulus characteristics, test equipment, or test paradigm on normative data for
existing measures, 2) the influence of subject age and gender on normative data, and 3)
intra-subject variability on repeated measures.
This protocol provides the construct for small, targeted normative studies and, subsequently,
there are no specific a priori hypotheses.
Study population:
Healthy volunteers ranging in age from 5-80 years will be studied under this protocol.
Design:
This protocol is designed to collect normative data on tests of audiometric and vestibular
function. Small sub-studies will be conducted on healthy volunteers in order to determine the
normal distribution of performance on defined subsets of hearing and/or balance tests. These
sub-studies will fall into one of the following five general categories: serial monitoring of
auditory function, auditory evoked potentials, auditory processing, middle ear function, and
vestibular function. All participants will have a basic hearing test and tympanometry to
confirm eligibility for the protocol. The subsequent measures of auditory or vestibular
function will depend on the defined subset of tests for which normative data is being sought.
Possible tests for normal data collection would include: middle ear function tests (MEF),
otoacoustic emissions (OAE), auditory evoked potentials (AEP), tests of auditory processing
(AP), computerized dynamic platform posturography (CDPP), vestibular evoked myogenic
potentials (VEMP), videonystagmography (VNG) and/or rotational vestibular testing (RVT).
The selection of tests for each sub-study will be determined either by the need to establish
control data for a patient population currently being evaluated under a collaborative
protocol, or to establish normative data on a test that will further expand our ability to
investigate specific pathology/function for which no equivalent published normative data are
available (e.g., otolith disease, auditory processing disorders). The specific tests that
each participant will perform will be clearly indicated and described in the consent/assent
documents and will be explained during the consent/assent process. Testing will be conducted
during a single outpatient clinic visit with the exception of measures for which test-retest
reliability is being investigated.
Outcome measures:
This is a normative data collection protocol designed to describe normal behavioral and
physiologic auditory and vestibular function for the NIH research population. Outcome
measures will vary from test to test and include one or more of the following: 1) response
threshold, amplitude, latency, velocity, frequency response, and/or accuracy, 2) number
and/or percent correct, 3) response repeatability, and 4) interaural response differences.
- INCLUSION CRITERIA:
Healthy adult volunteers:
- Healthy adults, aged 18-80 years
- Able to provide informed consent
- Normal hearing sensitivity, defined as pure-tone thresholds less than or equal to 25
dB HL, or when the pure-tone threshold exceeds 25 dB HL, it must be less than or equal
to the median threshold for the appropriate gender- and age-based group, for 250-8000
Hz (Morrell et al, 1996, ISO-7029, 2000).
- No air-bone gaps in excess of 10 dB for 500-4000 Hz.
- Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally,
defined as middle ear pressure between more or less 100 decaPascals, and peak
compensated static compliance between 0.3-1.5 milliliters (Margolis & Heller, 1987)
- American English as a first language for those participating in an auditory processing
sub-study.
- Able to refrain from caffeine and alcohol for 48 hours before vestibular study
sessions because both agents may modify the test results
EXCLUSION CRITERIA:
- History of auditory and/or vestibular disorders (e.g., Meniere s syndrome,
labyrinthitis).
- Evidence of active outer or middle ear disease or anomaly (e.g. otitis media, stenotic
ear canal, otorrhea)
- History of chronic (fluid in middle ear for more than 4 months) or recurrent otitis
media (more than 4 episodes of acute otitis media in one year)
- History of ear surgery other than PE tubes
- Current PE tubes
- History of treatment with ototoxic medications (e.g. cisplatin, aminoglycoside
antibiotics)
- Unable to discontinue medications that can interfere with vestibular test results for
the 48 hours immediately preceding a vestibular study session. These include any and
all anti-dizziness medications (such as Antivert), prescription pain medications (such
as Percocet), prescription headache medications (such as Imitrex), sleeping pills
(such as Ambien), anti-seizure medications (such as Topamax), and/or antihistamines
(such as Benadryl).
- Current diagnosis from the Diagnostic and Statistical Manual of Mental Disorders (DSM
IV) of a psychiatric disorder or on medications for a psychiatric disorder in the past
two years, including any or all antidepressants, anxiolytics, or psychostimulant
drugs.
- Cognitive impairment as evidenced by a score <26 on the Montreal Cognitive Assessment
(MoCA).
- Attention deficit hyperactivity disorder (ADHD) as evidenced by a score of greater
than or equal than or equal to 4 on the Adult ADHD Self Report Scale (Kessler et al.,
2005).
- History or diagnosis of a central nervous system disorder, including but not limited
to:
- Intracranial tumors
- Cerebrovascular disease
- Degenerative CNS disorder
- CNS trauma
- Encephalitis
- Meningitis
- Current diagnosis of speech and/or language disorders, autism, auditory neuropathy, or
auditory processing disorder; or in therapy for these disorders in past 2 years.
- Reduced visual acuity preventing ability to see the visual targets used for vestibular
and balance testing as evidenced by corrected visual acuity worse than 20/25 on a
Snellen chart for those participating in vestibular sub-studies.
- Ocular motor impairment preventing ability accurately follow the visual target used
for calibration and/or ocular motor tasks for those participating in the vestibular
sub-studies.
- Employees and staff of the Audiology Unit, Otolaryngology Branch, NIDCD.
- Reduced balance or postural instability as evidenced by a Timed Up and Go score
greater than or equal to 11.1 seconds (Whitney et al., 2004) for adults <65 years of
age and >12.6 seconds for adults 65-80 years of age (Shumway-Cook et al.,2000) and/or
Activities-specific Balance Confidence Score <67% (Lajoie & Gallagher, 2004) for those
participating in vestibular sub-studies.
Healthy children volunteers:
INCLUSION CRITERIA:
- Healthy children, aged 5 years-0 months to 17 years-11 months
- Normal hearing sensitivity, defined as pure-tone thresholds of 15 dB HL or better for
250-8000 Hz
- Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally,
defined as middle ear pressure between more or less 100 decaPascals, and peak
compensated static compliance between 0.2-1.5 milliliters (Margolis & Heller, 1987)
- American English as a first language for those participating in an auditory processing
sub-study.
- Ability to follow the verbal instructions and commands for study tests
- Able to refrain from alcohol and caffeine intake for 48 hours before vestibular study
sessions because caffeine may modify the test results
- Weight greater than 40 pounds for those participating in vestibular sub-studies that
include posturography
EXCLUSION CRITERIA:
- History of auditory and/or vestibular disorders (e.g. Meniere syndrome, enlarged
vestibular aqueduct).
- Evidence of active outer or middle ear disease or anomaly (e.g. otitis media, stenotic
ear canal, otorrhea)
- History of chronic (fluid in middle ear for more than 4 months) or recurrent otitis
media (more than 4 episodes of acute otitis media in one year)
- History of ear surgery other than PE tubes
- Current PE tubes
- History of treatment with ototoxic medications (e.g. cisplatin, aminoglycoside
antibiotics)
- Unable to discontinue medications that can interfere with vestibular test results for
the 48 hours immediately preceding a vestibular study session. These include any and
all anti-dizziness medications (such as Antivert), prescription pain medications (such
as Percocet), prescription headache medications (such as Imitrex), sleeping pills
(such as Ambien), anti-seizure medications (such as Topamax), and/or antihistamines
(such as Benadryl).
- Current diagnosis from the Diagnostic and Statistical Manual of Mental Disorders (DSM
IV) of a psychiatric disorder or on medications for psychiatric disorder in the past
two years, including any or all antidepressants, anxiolytics, or psychostimulant
drugs.
- Cognitive impairment as evidenced by a standard score less than 85 on the Peabody
Picture Vocabulary Test (Fourth Edition) (Dunn and Dunn, 2007)
- Attention deficit hyperactivity disorder (ADHD) as evidenced by a score of greater
than or equal to 6 on the SNAP IV (Swanson, et al., 2001)
- History or previous diagnosis of a central nervous system disorder, including but not
limited to:
- Intracranial tumors
- Cerebrovascular disease
- Degenerative CNS disorder
- CNS trauma
- Encephalitis
- Meningitis
- Current diagnosis of speech and/or language disorders or delays, autism, auditory
neuropathy, or auditory processing disorder; or in therapy of these disorders in past
2 years.
- Reduced visual acuity preventing ability to see the visual targets used for vestibular
and balance testing as evidenced by corrected visual acuity worse than 20/25 on a
Snellen chart for those participating in vestibular sub-studies.
- Ocular motor impairment preventing ability to see or accurately follow the visual
target used for ocular motor tasks for those participating in the vestibular
sub-studies.
- Reduced balance or postural instability as evidenced by a Timed Up and Go score of
greater than or equal to 9.4 seconds (Itzkowitz et al., 2016) for those participating
in vestibular sub-studies.
- Employees and staff of the Audiology Unit, Otolaryngology Branch, NIDCD.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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