Trial record 15 of 109 for:    NIDCD

Normal Values in Hearing and Balance Testing

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01629108
First received: June 22, 2012
Last updated: May 9, 2014
Last verified: April 2014
  Purpose

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.

Condition
Healthy Volunteer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Normative Values in Audiovestibular Testing

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 500
Study Start Date: June 2012
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Healthy adult volunteers:

  • Healthy adults, aged 18-70 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 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 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.
  • Visual or ocular motor impairment preventing ability to see or accurately follow the visual target used for calibration and/or ocular motor tasks for those participating in the vestibular sub-studies.

INCLUSION CRITERIA:

Healthy children volunteers:

  • 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.
  • Visual or 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629108

Contacts
Contact: Carmen C Brewer, Ph.D. (301) 496-5294 brewerc@nidcd.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Carmen C Brewer, Ph.D. National Institute on Deafness and Other Communication Disorders (NIDCD)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01629108     History of Changes
Other Study ID Numbers: 120152, 12-DC-0152
Study First Received: June 22, 2012
Last Updated: May 9, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Normative Data
Vestibular
Auditory
Healthy Volunteers
Hearing

ClinicalTrials.gov processed this record on July 26, 2014