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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02345876
Other study ID # 2013-799
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 11, 2014
Est. completion date July 3, 2019

Study information

Verified date July 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date July 3, 2019
Est. primary completion date July 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 11 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention


Locations

Country Name City State
France Centre Hospitzlier Le Vinatier Bron
France Service ORL CHU Montpied Clermont-Ferrand
France Service d'Audiologie et Explorations Orofaciales Centre de Référence des Troubles des Apprentissages Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of The Asymmetry Index of the efferent system at 2 years interval 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 Day 1 and then at least 2 years (± 4 weeks)
Secondary Change in the level of reading skill Behavioral measure Day 1 and then at least 2 years (± 4 weeks)
Secondary Change in the percentage of correct answers obtained during a speech perception test in silence and noise. Oral repetition of VCV Day 1 and then at least 2 years (± 4 weeks)
Secondary 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) Presentation of different speech material to both ears simultaneously Day 1 and then at least 2 years (± 4 weeks)
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