NCT02345876

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

5.3 years

First QC Date

December 9, 2014

Last Update Submit

July 17, 2019

Conditions

Keywords

Dyslexia, Medial olivocochlear system, Maturation, Auditory Processing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in the level of reading skill

    Day 1 and then at least 2 years (± 4 weeks)

  • Change in the percentage of correct answers obtained during a speech perception test in silence and noise.

    Day 1 and then at least 2 years (± 4 weeks)

  • 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)

    Day 1 and then at least 2 years (± 4 weeks)

Study Arms (2)

Dyslexic children

Longitudinal follow-up without intervention

Other: no intervention

Normal reading children

Longitudinal follow-up without intervention

Other: no intervention

Interventions

Dyslexic childrenNormal reading children

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitzlier Le Vinatier

Bron, 69500, France

Location

Service ORL CHU Montpied

Clermont-Ferrand, 63003, France

Location

Service d'Audiologie et Explorations Orofaciales Centre de Référence des Troubles des Apprentissages

Lyon, France

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2014

First Posted

January 26, 2015

Study Start

March 11, 2014

Primary Completion

July 3, 2019

Study Completion

July 3, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations