Normal Values in Hearing and Balance Testing
|First Received Date ICMJE||June 22, 2012|
|Last Updated Date||August 4, 2016|
|Start Date ICMJE||June 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Normative data for behavioral and physiologic auditory and vestibular function including 1) response threshold, amplitude, latency, velocity, repeatability, frequency response, accuracy, 2) percent correct and/or inteural response differences. [ Time Frame: 03/31/2018 ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01629108 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Normal Values in Hearing and Balance Testing|
|Official Title ICMJE||Normative Values in Audiovestibular Testing|
- 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.
- To test different types of hearing and balance tests, and collect information on normal values for each test.
- Healthy volunteers between 5 and 70 years of age.
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.
Healthy volunteers ranging in age from 5-70 years will be studied under this protocol.
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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Healthy Volunteer|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Healthy adult volunteers:
Healthy children volunteers:
|Ages||5 Years to 70 Years (Child, Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01629108|
|Other Study ID Numbers ICMJE||120152, 12-DC-0152|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute on Deafness and Other Communication Disorders (NIDCD)|
|Study Sponsor ICMJE||National Institute on Deafness and Other Communication Disorders (NIDCD)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP