NCT00004570

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
875

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 1999

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 14, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2000

Completed
18.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
Last Updated

September 20, 2018

Status Verified

September 18, 2018

First QC Date

February 14, 2000

Last Update Submit

September 19, 2018

Conditions

Keywords

Temporal ProcessingLanguage ImpairmentLinkage AnalysisInheritanceLanguage DelayHealthyAuditory Temporal Processing DisorderSpeech Impediment

Eligibility Criteria

Age6 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 2690915BACKGROUND
  • Bishop 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.

    PMID: 7886145BACKGROUND
  • Tomblin 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.

    PMID: 9430746BACKGROUND

MeSH Terms

Conditions

Auditory Perceptual DisordersLanguage Development DisordersLanguage DisordersSpeech Disorders

Condition Hierarchy (Ancestors)

Auditory Diseases, CentralRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersCommunication Disorders

Study Officials

  • Carmen C Brewer, Ph.D.

    National Institute on Deafness and Other Communication Disorders (NIDCD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2000

First Posted

February 15, 2000

Study Start

January 31, 1999

Study Completion

September 18, 2018

Last Updated

September 20, 2018

Record last verified: 2018-09-18

Locations