Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT01629108
Eligibility Criteria:
* 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
* 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.
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 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.
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
* 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 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)
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
80 Years
Study:
NCT01629108
Study Brief:
Protocol Section:
NCT01629108