- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02345876
Maturation of Auditory Processing in Children With Dyslexia Compared to Average-reading Children (ASTRAUCOLE)
July 17, 2019 updated by: Hospices Civils de Lyon
Asymmetry, Auditory Processing and Reading Skills in Phonological Dyslexic Children Compared to Average-reading Children
The hypothesis of central auditory processing disorders has been advanced to explain the anomalies of the grapheme/phoneme combination in some dyslexia.
These phonological disorders may be linked to abnormalities of the efferent (medial olivocochlear) system modulation and of cortical asymmetry.
Indeed, the efferent system has an asymmetry in relation to handedness.
Thus, in right-handed subject, it is predominant on the right side.
In contrast, in the subject-handed dyslexic, the efferent system tends to be right-lateralized or non-lateralized.
However, after an audio-visual training, normal lateralization can appear.
This maturation of the efferent system lateralization during reading acquisition seems to have a particular profile in dyslexics with phonological disorder, especially if it is persistent.
This finding allows to consider new prognostic evaluation and speech therapy rehabilitation in the dyslexic child.
Study Overview
Study Type
Observational
Enrollment (Actual)
161
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bron, France, 69500
- Centre Hospitzlier Le Vinatier
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Clermont-Ferrand, France, 63003
- Service ORL CHU Montpied
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Lyon, France
- Service d'Audiologie et Explorations Orofaciales Centre de Référence des Troubles des Apprentissages
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 11 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
For the dyslexic children: primary care clinic and speech therapists For the normal reading children : elementary schools of Lyon and Clermond-Ferrand and their suburbs
Description
Common inclusion criteria
- Native French speaker and french education
- No medical treatment for behavior or neurological disorders (as epilepsy)
- Normal or corrected vision
- Right-handed children (Edinburgh tets (Oldfield, 1971): >+50%)
- Normal ORL examination
- No hearing loss : hearing thresholds not above 15 dB between 250 and 4 000 Hz
- Presence of Otoacoustic Emissions (Total amplitude < 5 dB or SNR > 3dB for at least 3 frequency bands between 1 and 4 kHz)
- Normal level of intellectual development
- Regular school attendance
For the normal reading children
- Aged from 6 to less than 11
- Normal reading level
For the dyslexic children
- Aged from 8 to less than 11
- Diagnostic of dyslexia made by a complet check-up during the 6 last months before the inclusion
Exclusion Criteria
- Neurological or psychiatric disease incompatible with the testing procedure
- Ear disease during more than 6 months
- Normal reading children who have repeat a year
- Previous speech therapy for normal reading children
- Not corrected visual acuteness
- Schooling in a foreign language
- Foreign language spoken at home with both parents
- Known hearing deficit
- Invalid social security
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dyslexic children
Longitudinal follow-up without intervention
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Normal reading children
Longitudinal follow-up without intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of The Asymmetry Index of the efferent system at 2 years interval
Time Frame: Day 1 and then at least 2 years (± 4 weeks)
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The change of the Asymmetry Index of the efferent system The Asymmetry Index is the difference between the equivalent attenuation measured on the right ear and the left ear.
Evoked otoacoustic emissions were recorded monaurally at five stimulus intensities ranging from 57 to 69 dB SPL in 3 dB steps, in random presentation order, with and without contralateral acoustic stimulation consisting of 30 dBSPL continuous broadband noise (speech-like noise) produced by an audiometer
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Day 1 and then at least 2 years (± 4 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the level of reading skill
Time Frame: Day 1 and then at least 2 years (± 4 weeks)
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Behavioral measure
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Day 1 and then at least 2 years (± 4 weeks)
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Change in the percentage of correct answers obtained during a speech perception test in silence and noise.
Time Frame: Day 1 and then at least 2 years (± 4 weeks)
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Oral repetition of VCV
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Day 1 and then at least 2 years (± 4 weeks)
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Change in percentage of correctly repeated stimuli which have been heard in both ears (binaural integration with divided attention) or in one indicated ear (binaural separation with selective attention)
Time Frame: Day 1 and then at least 2 years (± 4 weeks)
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Presentation of different speech material to both ears simultaneously
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Day 1 and then at least 2 years (± 4 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 11, 2014
Primary Completion (ACTUAL)
July 3, 2019
Study Completion (ACTUAL)
July 3, 2019
Study Registration Dates
First Submitted
December 9, 2014
First Submitted That Met QC Criteria
January 19, 2015
First Posted (ESTIMATE)
January 26, 2015
Study Record Updates
Last Update Posted (ACTUAL)
July 18, 2019
Last Update Submitted That Met QC Criteria
July 17, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-799
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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