NCT00001957

Brief Summary

This study aims to increase our understanding of the difficulty people have recognizing the spoken word, especially in noisy situations. Subjects must be between 12 and 18 years old with no history of voice disorder, autism, stuttering, aphasia, multiple sclerosis, traumatic brain injury, severe language disorders, and psychiatric disorders. Group A subjects must show reduced speech-in-noise scores and Group B subjects must demonstrate speech-in-noise scores within normal limits. The child will perform a series of hearing tasks that will take from 1.5 to 2 hours, with a break halfway through. A routine hearing test will be given. The child will sit in a sound-treated room wearing earphones and will depress a button in response to sound or to repeat words. The words may be in quiet or mixed with noise. In a test called "immitance," air pressure change and tones will be sent through a miniature probe in the ear for about 1 minute. TEOAE (transient-evoked otoacoustic emission) testing will test the inner ear with clicking sounds. At times, noise will be presented through a probe in the opposite ear. The child will listen to a series of recordings of speech in quiet and in noise and will be asked to repeat what is heard. These recordings will include monosyllabic words with some part of the sounds cut out; words presented with several voices speaking together; two words presented at the same time, one to each ear (child must repeat both words); and two sentences presented at the same time, one to each ear (child must repeat sentence presented to chosen ear). The only risk in this study is tiredness from listening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2000

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2003

First QC Date

January 18, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

Ostoacoustic EmissionCentral Auditory ProcessingCAPDMedial Olivocochlear BundleSpeech Impediment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects selected will be between the ages of 12 and 18 years.
  • All subjects must score within normal limits on measures of threshold sensitivity, speech recognition in quiet, middle ear function and TEOAEs to be included in the study.
  • Group A subjects must be identified as having learning or attention problems in school and show show reduced scores on speech-in-noise tasks.
  • Group B subjects must demonstrate speech-in-noise scores within normal limits.
  • Groups will be matched for sex, age and handedness.

You may not qualify if:

  • Subjects will be excluded for history of voice disorders, autism, stuttering, aphasia, multiple sclerosis, traumatic brain injury, severe language disorders and psychiatric disorders.
  • Children who are being treated for hyperactivity disorder will be excluded.
  • Children who are taking medication prescribed for hyperactivity, anxiety or depression may be excluded.
  • Children younger than 12 will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Deafness and Other Communication Disorders (NIDCD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Berlin CI, Hood LJ, Wen H, Szabo P, Cecola RP, Rigby P, Jackson DF. Contralateral suppression of non-linear click-evoked otoacoustic emissions. Hear Res. 1993 Dec;71(1-2):1-11. doi: 10.1016/0378-5955(93)90015-s.

    PMID: 8113128BACKGROUND
  • Collet L. Use of otoacoustic emissions to explore the medial olivocochlear system in humans. Br J Audiol. 1993 Apr;27(2):155-9. doi: 10.3109/03005369309077907.

    PMID: 8220283BACKGROUND
  • Collet L, Kemp DT, Veuillet E, Duclaux R, Moulin A, Morgon A. Effect of contralateral auditory stimuli on active cochlear micro-mechanical properties in human subjects. Hear Res. 1990 Jan;43(2-3):251-61. doi: 10.1016/0378-5955(90)90232-e.

    PMID: 2312416BACKGROUND

MeSH Terms

Conditions

Auditory Diseases, CentralSpeech Disorders

Condition Hierarchy (Ancestors)

Retrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 18, 2000

First Posted

January 19, 2000

Study Start

November 1, 1999

Study Completion

November 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-11

Locations