Auditory Perceptual DisorderNCT00004570
Hereditary Deficits in Auditory Processing Leading to Language Impairment
An observational study of Auditory Perceptual Disorder and Language Delay, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 85 years
- Conditions the study is for
- Auditory Perceptual Disorder, Language Delay, Language Disorder
- How many people
- 875 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 1999to 18 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Identification of Hereditary Auditory Temporal Processing Deficits
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.
Read the detailed description
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>
- Keywords
- Temporal Processing, Language Impairment, Linkage Analysis, Inheritance, Language Delay, Healthy, Auditory Temporal Processing Disorder, Speech Impediment
- Medical subject headings
- Auditory Perceptual Disorders, Language Development Disorders, Language Disorders, Speech Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2000 (estimated)
- Study start31 Jan 1999
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Auditory Perceptual DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 875 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Carmen C Brewer, Ph.D., Principal investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004570
- Sponsor's protocol ID
- 000073
- Other IDs
- 00-DC-0073
- Status last verified
- 18 Sep 2018
- First submitted
- 14 Feb 2000
- Last updated
- 20 Sep 2018
- Results posted
- No
Publications
Bishop DV. Autism, Asperger's syndrome and semantic-pragmatic disorder: where are the boundaries? Br J Disord Commun. 1989 Aug;24(2):107-21. doi: 10.3109/13682828909011951.
PubMed 2690915Bishop DV. Is specific language impairment a valid diagnostic category? Genetic and psycholinguistic evidence. Philos Trans R Soc Lond B Biol Sci. 1994 Oct 29;346(1315):105-11. doi: 10.1098/rstb.1994.0134.
PubMed 7886145Tomblin JB, Records NL, Buckwalter P, Zhang X, Smith E, O'Brien M. Prevalence of specific language impairment in kindergarten children. J Speech Lang Hear Res. 1997 Dec;40(6):1245-60. doi: 10.1044/jslhr.4006.1245.
PubMed 9430746
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Hereditary Auditory Temporal Processing Deficits
- ClinicalTrials.gov ID
- NCT00004570
- Acronym / sponsor ID
- 000073
- Keywords
- Temporal Processing, Language Impairment, Linkage Analysis, Inheritance, Language Delay, Healthy, Auditory Temporal Processing Disorder, Speech Impediment
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 875 participants (actual)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 31 Jan 1999
- Study completion
- 18 Sep 2018
- First posted
- 15 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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>
Study design
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
- Intracranial tumors
- Cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Background: PubMed 2690915Bishop DV. Autism, Asperger's syndrome and semantic-pragmatic disorder: where are the boundaries? Br J Disord Commun. 1989 Aug;24(2):107-21. doi: 10.3109/13682828909011951.
- Background: PubMed 7886145Bishop DV. Is specific language impairment a valid diagnostic category? Genetic and psycholinguistic evidence. Philos Trans R Soc Lond B Biol Sci. 1994 Oct 29;346(1315):105-11. doi: 10.1098/rstb.1994.0134.
- Background: PubMed 9430746Tomblin JB, Records NL, Buckwalter P, Zhang X, Smith E, O'Brien M. Prevalence of specific language impairment in kindergarten children. J Speech Lang Hear Res. 1997 Dec;40(6):1245-60. doi: 10.1044/jslhr.4006.1245.
Related trials for Auditory Perceptual Disorder
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Not yet recruiting
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Schizophrenia Disorder, Schizoaffecitve Disorder
Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Schizophrenia, Auditory Verbal Hallucinations
Recruiting
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Schizophrenia, Hallucinations, Auditory
Not yet recruitingObservational study
Building a Computational Model of Auditory Hallucinations
Schizophrenia / Schizoaffective Disorder, Schizophrenia and Disorders With Psychotic Feature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen C Brewer, Ph.D. principal investigator
National Institute on Deafness and Other Communication Disorders (NIDCD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auditory Perceptual Disorder and Language Delay, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004570, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.