Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Healthy Volunteer
Type
Observational
Design
Observational Model: CohortTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 5 years and 80 years
Gender
Both males and females

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 upgr...

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.

Tracking Information

NCT #
NCT01629108
Collaborators
Not Provided
Investigators
Principal Investigator: Carmen C Brewer, Ph.D. National Institute on Deafness and Other Communication Disorders (NIDCD)