Suspended

Identification of Hereditary Auditory Temporal Processing Deficits

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What is being collected

Data Collection

Who is being recruted

Auditory Diseases, Central+17

+ Mental Disorders

+ Brain Diseases

From 6 to 85 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: January 1999
See protocol details

Summary

Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: September 20, 2018
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Study start date: January 31, 1999

Actual date on which the first participant was enrolled.

Objective Recent research implicates auditory processing deficits in the etiology of language impairments, but no standard methodology has been employed to determine whether auditory processing deficits are heritable traits. We will investigate whether auditory processing skills and auditory processing disorders (APDs) are hereditary. Study Population We will study same-sex twins (healthy volunteers) and individuals who score in the top or bottom 10th percentile on auditory processing tests and their first-degree family members. Design: A Two-Phase, Staged Study Our approach uses the two classical methods of demonstrating heritability: comparison of monozygotic (MZ) to dizygotic (DZ) concordance rates in twins and measuring familial aggregation of a trait. While there are a variety of auditory processing tests in common use, there is no standard battery of tests for the diagnosis of APD. Moreover, the normal variation in performance on many of these tests is not known. We will systematically evaluate tests of auditory processing for variation in the general population and for evidence of heritability. Phase 1 Twin study We will evaluate a variety of auditory processing tests in MZ and same-sex DZ twins. This initial phase of the study is designed to provide data so that the performance of MZ twin pairs can be compared to the performance of DZ twin pairs. Statistical modeling will be used to estimate the relative contributions of heredity and environment to auditory processing skills. In addition, we will examine variation in auditory processing skills in the general population of twins. This will allow us to identify auditory processing skills and tests that have the greatest heritable components, and to establish normative data for the tests we administer. Phase 2 Family aggregation study Based on the outcomes of Phase 1, auditory processing tests of skills with the highest heritable component will be selected for evaluation of probands. Those who score in the top and bottom 10th percentile will be eligible for participation as probands in this phase of the study. Variation of these skills in the general population, as determined by the twin data (Phase 1) or published norms, when they are available, will be used to determine the top and bottom 10th percentiles. This same test set will be administered to probands and at least two first-degree relatives allowing us to determine whether traits related to auditory processing occur within the family at a rate greater than chance. Outcome Measures Phase 1 outcome measures will be individual performance on tests of auditory processing skills and comparative performance of MZ and DZ co-twin pairs on these tests. Phase II outcome measures will be the performance on auditory processing measures of probands and their family members, and affectance rates observed in these families.<TAB>

NCT00004570
Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: September 20, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

875 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Auditory Diseases, CentralMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersCommunication DisordersEar DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesPerceptual DisordersRetrocochlear DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurocognitive DisordersAuditory Perceptual DisordersLanguage Development DisordersLanguage DisordersSpeech Disorders

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

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SuspendedOne Study Center