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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 14, 2000 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | February 2000 | ||||||||
| Estimated Primary Completion Date | October 2003 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00004570 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Hereditary Deficits in Auditory Processing Leading to Language Impairment | ||||||||
| Official Title ICMJE | Identification of Hereditary Auditory Temporal Processing Deficits | ||||||||
| Brief 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. |
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| Detailed Description | 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 are presently evaluating a battery of auditory processing measures in twins recruited from the general population. Our data indicates that performance on some of these tests has a significantly heritable component. We seek IRB approval to recruit these research subjects and their families into genetic studies to investigate the heritability of auditory temporal processing characteristics, and identify the causative genes. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 800 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | October 2003 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Diagnosis of auditory processing disorder (APD/CAPD) based on two or more standardized tests of auditory processing. Age 6 to 85 years. EXCLUSION CRITERIA: Hearing loss with onset prior to age 20 years, defined as:
History of chronic/recurrent otitis media History of ear surgery History or diagnosis of central nervous system lesions/pathology, including:
Currently on medications capable of altering CNS function History of treatment with ototoxic medication History or diagnosis of:
Non-English Speaking English as a second language Diagnosis of auditory neuropathy |
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| Gender | Both | ||||||||
| Ages | 6 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00004570 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 000073, 00-DC-0073 | ||||||||
| Study Sponsor ICMJE | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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