Normal Values in Hearing and Balance Testing
This study aims to understand what is considered "normal" for various hearing and balance tests. Researchers at the National Institutes of Health (NIH) want to collect information from healthy volunteers to create a reference for these tests. This will help them determine when a test result indicates a problem and when it falls within a healthy range. The study will also help identify the best ways to perform these tests. You may be eligible if you are a healthy volunteer between 5 and 80 years old with normal hearing.
- Study design
- This is an observational study designed to collect data from approximately 500 healthy volunteers. It will involve a single visit to the NIH Clinical Center.
- What's involved
- You would have a single visit to the National Institutes of Health Clinical Center, which will include screening tests and study tests of hearing and balance.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
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NCT01629108
Normal Values in Hearing and Balance Testing
Recruiting
Not specifiedAges 5–80ObservationalNational Institute on Deafness and Other Communication Disorders (NIDCD)Government-funded
~500 participants
Updated 2026-08-17 on ClinicalTrials.gov
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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 interaural response differences
Measured over Varies from test to test
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Gayla L Poling, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institute on Deafness and Other Communication Disorders (NIDCD)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Healthy adults, aged 18-80 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
American English as a first language for those participating in study tasks evaluating auditory processing.
Able to refrain from caffeine and alcohol for 48 hours before vestibular study sessions because both agents may modify the test results.
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
American English as a first language for those participating in study tasks evaluating auditory processing.
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 tasks that include CDDP
Exclusion
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 score \<26 on the Montreal Cognitive Assessment (MoCA).
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).
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.
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.
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.
Employees and staff of the Audiology Unit, Otolaryngology Branch, NIDCD.
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.
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)
Attention deficit hyperactivity disorder (ADHD) as evidenced by a score of greater than or equal to 6 on the SNAP IV
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.
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 study tasks.
Ocular motor impairment preventing ability to see or accurately follow the visual target used for ocular motor tasks for those participating in the vestibular study tasks.
Reduced balance or postural instability as evidenced by a Timed Up and Go score of greater than or equal to 9.4 seconds for those participating in vestibular study tasks.
What this trial 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 interaural response differencesVaries from test to test
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.