Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT01629108
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2012-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Normal Values in Hearing and Balance Testing
Sponsor:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Organization:
Study Overview
Official Title:
Normative Values in Audiovestibular Testing
Status:
RECRUITING
Status Verified Date:
2025-08-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 80 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 80 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.
Detailed Description:
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 study tasks 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 study tasks 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 study tasks 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 study tasks 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 study tasks 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 study tasks 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12-DC-0152 | None | None | View |