Hereditary Deficits in Auditory Processing Leading to Language Impairment (NCT00004570) | Clinical Trial Compass
TerminatedNot Applicable
Hereditary Deficits in Auditory Processing Leading to Language Impairment
United States875 participantsStarted 1999-01-31
Plain-language summary
Some children with certain language disorders may not properly process the sounds they hear, resulting in language impairments. The purpose of this study is to determine if deficits in auditory temporal processing the way the brain analyzes the timing and patterns of sounds are an inherited trait.
Families with auditory temporal processing deficits are sought in order to identify the genes responsible for auditory temporal processing deficits. Children and adults with a diagnosis or history of language impairment in the family and their family members both affected and non-affected are eligible for this two-part study. In Part 1, participants undergo a series of language tests and listening tests to measure various characteristics of how they perceive sound. In Part 2, they are interviewed about language disorders, learning disabilities, and other medical problems of family members. This information is used to construct a pedigree (family tree diagram) showing the pattern of inheritance of family traits. Study subjects whose pedigree indicates that language disorders may be hereditary in their family will provide either a small blood sample (1 to 2 tablespoons) or a tissue specimen obtained from a cheek swab (rubbing the inside of the cheek with a small brush or cotton swabs). The sample will be used to isolate DNA for genetic analysis.
Who can participate
Age range
6 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
6-85 years of age
Native English speaker, with English as the first language
Phase 1 Same sex twins (MZ or DZ) and both willing and able to participate in test procedures.
Phase 2 Score in the top or bottom 10th percentile on tests of auditory processing or are a first-degree relative of someone who scores in the top or bottom 10th percentile and are willing and able to participate in the test procedures.
EXCLUSION CRITERIA:
Hearing loss, defined as air conduction pure tone thresholds (250-8000 Hz) exceeding 20 dBHL; air-bone gaps, even in the presence of normal hearing sensitivity, exceeding 10 dBHL; and/or abnormal tympanometry.
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.
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
* Auditory neuropathy
* Attention deficit hyperactivity disorder (ADHD)
* Attention deficit disorder (ADD)
Currently taking medications capable of altering CNS function (e.g. antidepressants, anxiolytics, or a psychostimulant drugs such as ritalin).
History of treatment with ototoxic medications that may affect ultrahigh frequency hearing (e.g. cisplatin, aminoglycoside antibiotics).
Unable to provide consent or assent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00004570
SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)