Central Auditory DiseaseNCT00001957
Testing a Possible Cause of Reduced Ability of Children to Process Speech in Noise
An observational study of Central Auditory Disease and Healthy, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Central Auditory Disease, Healthy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Nov 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Deafness and Other Communication Disorders (NIDCD)
Bethesda, Maryland, 20892
About this study
Official title: TEOAE Suppression in Children With Auditory Processing Difficulty
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.
Read more
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.
Read the detailed description
Five to ten percent of school-age children in the United States are identified as having learning disability and 10 to 20% have attention deficit hyperactivity disorder (ADHD). Many of these children have difficulty with tasks that challenge the auditory system. It is estimated that 3 to 7 percent of children have difficulty with auditory processing as a major factor interfering with education (Chermak and Musiek, 1997). Pinpointing physiological causes of auditory processing difficulty has been elusive. Intervention is hampered by the lack of knowledge of possible physical causes and therefore intervention addresses systems rather than causes of auditory processing difficulty. Indeed, whether the problem has a peripheral or central origin is unclear. Identification of physiological differences in children with auditory processing disorders may lead to electrophysiologic identification of potential auditory processing disorders. Thus the possibility of early intervention might reduce the educational impact of this problem.
The aim of this study is to investigate the relationship of the efferent auditory neural system to the ability to process speech in noise. The study measures suppression of otoacoustic emissions in a population of adolescents with auditory processing difficulty as demonstrated by reduced ability to process speech in noise (Group A). These subjects will be compared to an age and sex matched group of adolescents with speech-in-noise test scores within normal limits (Group B). The study population will include 100 children between the ages of 12 and 18 years. All subjects must demonstrate normal puretone thresholds, speech recognition scores in quiet and middle ear function measured by acoustic immittance tests. Furthermore, the subjects' otoacoustic emissions must have reproducibility percentages within normal limits in the 2000, 3000, 4000 and 5000 Hz frequency bands. Subjects will complete an auditory speech recognition test battery (Scan-A and NU6 in multi-talker noise) and otoacoustic emission suppression tests. The auditory recognition tests each measure the subjects' ability to recognize speech in the presence of various types of noise and/or filtering. A group design will be used. Outcome parameters are the amount of suppression in dB for a group of subjects with normal speech understanding in noise and a group with reduced speech scores in noise and the relationship between speech measures and the degree of suppression.
- Conditions
- Central Auditory Disease, Healthy
- Keywords
- Ostoacoustic Emission, Central Auditory Processing, CAPD, Medial Olivocochlear Bundle, Speech Impediment
- Medical subject headings
- Auditory Diseases, Central, Speech Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2000 (estimated)
- Study startNov 1999
- Study completionNov 2003
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 Central Auditory DiseaseStudies 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001957
- Sponsor's protocol ID
- 000016
- Other IDs
- 00-DC-0016
- Status last verified
- Nov 2003
- First submitted
- 18 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 8113128Collet 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.
PubMed 8220283Collet 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.
PubMed 2312416
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEOAE Suppression in Children With Auditory Processing Difficulty
- ClinicalTrials.gov ID
- NCT00001957
- Acronym / sponsor ID
- 000016
- Conditions
- Central Auditory Disease, Healthy
- Keywords
- Ostoacoustic Emission, Central Auditory Processing, CAPD, Medial Olivocochlear Bundle, Speech Impediment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- Nov 1999
- Study completion
- Nov 2003
- First posted
- 19 Jan 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.
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.
Detailed description
Five to ten percent of school-age children in the United States are identified as having learning disability and 10 to 20% have attention deficit hyperactivity disorder (ADHD). Many of these children have difficulty with tasks that challenge the auditory system. It is estimated that 3 to 7 percent of children have difficulty with auditory processing as a major factor interfering with education (Chermak and Musiek, 1997). Pinpointing physiological causes of auditory processing difficulty has been elusive. Intervention is hampered by the lack of knowledge of possible physical causes and therefore intervention addresses systems rather than causes of auditory processing difficulty. Indeed, whether the problem has a peripheral or central origin is unclear. Identification of physiological differences in children with auditory processing disorders may lead to electrophysiologic identification of potential auditory processing disorders. Thus the possibility of early intervention might reduce the educational impact of this problem.
The aim of this study is to investigate the relationship of the efferent auditory neural system to the ability to process speech in noise. The study measures suppression of otoacoustic emissions in a population of adolescents with auditory processing difficulty as demonstrated by reduced ability to process speech in noise (Group A). These subjects will be compared to an age and sex matched group of adolescents with speech-in-noise test scores within normal limits (Group B). The study population will include 100 children between the ages of 12 and 18 years. All subjects must demonstrate normal puretone thresholds, speech recognition scores in quiet and middle ear function measured by acoustic immittance tests. Furthermore, the subjects' otoacoustic emissions must have reproducibility percentages within normal limits in the 2000, 3000, 4000 and 5000 Hz frequency bands. Subjects will complete an auditory speech recognition test battery (Scan-A and NU6 in multi-talker noise) and otoacoustic emission suppression tests. The auditory recognition tests each measure the subjects' ability to recognize speech in the presence of various types of noise and/or filtering. A group design will be used. Outcome parameters are the amount of suppression in dB for a group of subjects with normal speech understanding in noise and a group with reduced speech scores in noise and the relationship between speech measures and the degree of suppression.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8113128Berlin 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.
- Background: PubMed 8220283Collet 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.
- Background: PubMed 2312416Collet 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Central Auditory Disease and Healthy, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 4 Mar 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT00001957, 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 4 Mar 2008.