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Protocol Details

Normative Values in Audiovestibular Testing

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-DC-0152

Sponsoring Institute

National Institute on Deafness and Other Communication Disorders (NIDCD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5
Max Age: 80

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Normative Data;
Vestibular;
Auditory;
Healthy Volunteers;
Hearing

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Deafness and Other Communication Disorders

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.

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Eligibility

INCLUSION CRITERIA:

Healthy adult volunteers:

-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 (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 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 sub-studies.

-Ocular motor impairment preventing ability accurately follow the visual target used for calibration and/or ocular motor tasks for those participating in the vestibular sub-studies.

-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% (Lajoie & Gallagher, 2004) for those participating in vestibular sub-studies.

Healthy children volunteers:

INCLUSION CRITERIA:

-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.

-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 sub-studies.

-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.

-Reduced balance or postural instability as evidenced by a Timed Up and Go score of greater than or equal to 9.4 seconds (Itzkowitz et al., 2016) for those participating in vestibular sub-studies.

-Employees and staff of the Audiology Unit, Otolaryngology Branch, NIDCD.


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Citations:

ATHERLEY GR, DINGWALL-FORDYCE I. THE RELIABILITY OF REPEATED AUDITORY THRESHOLD DETERMINATION. Br J Ind Med. 1963 Jul;20:231-5.

Aust G, Hordinsky JR, Schmelzer B. Male and female characteristics in vestibular testing: a step toward the selection of the best participants for space flight. Acta Astronaut. 1980 Nov;7(11):1323-31.

Barber HO, Wright G. Positional nystagmus in normals. Adv Otorhinolaryngol. 1973;19:276-83.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Carmen C. Brewer, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
BG 10 RM 5C306
10 CENTER DR
BETHESDA MD 20814
(301) 496-5294
brewerc@nidcd.nih.gov

Carmen C. Brewer, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
BG 10 RM 5C306
10 CENTER DR
BETHESDA MD 20814
(301) 496-5294
brewerc@nidcd.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01629108

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