RECRUITING

Normal Values in Hearing and Balance Testing

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Healthy VolunteerNormative DataVestibularAuditoryHealthy VolunteersHearingNatural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Normative Values in Audiovestibular Testing

Quick Facts

Study Start:2012-09-21
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01629108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy adults, aged 18-80 years
  2. * Able to provide informed consent
  3. * 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).
  4. * No air-bone gaps in excess of 10 dB for 500-4000 Hz.
  5. * 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
  6. * American English as a first language for those participating in study tasks evaluating auditory processing.
  7. * Able to refrain from caffeine and alcohol for 48 hours before vestibular study sessions because both agents may modify the test results.
  1. * History of auditory and/or vestibular disorders (e.g., Meniere s syndrome, labyrinthitis).
  2. * Evidence of active outer or middle ear disease or anomaly (e.g. otitis media, stenotic ear canal, otorrhea)
  3. * 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)
  4. * History of ear surgery other than PE tubes
  5. * Current PE tubes
  6. * History of treatment with ototoxic medications (e.g. cisplatin, aminoglycoside antibiotics)
  7. * 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).
  8. * 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.
  9. * Cognitive impairment as evidenced by a score \<26 on the Montreal Cognitive Assessment (MoCA).
  10. * 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).
  11. * History or diagnosis of a central nervous system disorder, including but not limited to:
  12. * Intracranial tumors
  13. * Cerebrovascular disease
  14. * Degenerative CNS disorder
  15. * CNS trauma
  16. * Encephalitis
  17. * Meningitis
  18. * 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.
  19. * 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 tasks.
  20. * Ocular motor impairment preventing ability accurately follow the visual target used for calibration and/or ocular motor tasks for those participating in the vestibular tasks.
  21. * Employees and staff of the Audiology Unit, Otolaryngology Branch, NIDCD.
  22. * 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% for those participating in vestibular study tasks.

Contacts and Locations

Study Contact

Christopher K Zalewski, Ph.D.
CONTACT
(301) 496-5145
zalewski@nidcd.nih.gov
Gayla L Poling, Ph.D.
CONTACT
(240) 841-9768
gayla.poling@nih.gov

Principal Investigator

Gayla L Poling, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)

  • Gayla L Poling, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-09-21
Study Completion DateN/A

Study Record Updates

Study Start Date2012-09-21
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Normative Data
  • Vestibular
  • Auditory
  • Healthy Volunteers
  • Hearing
  • Natural History

Additional Relevant MeSH Terms

  • Healthy Volunteer