DyslexiaASTRAUCOLENCT02345876
Maturation of Auditory Processing in Children With Dyslexia Compared to Average-reading Children
An observational study of Dyslexia, run by Hospices Civils de Lyon at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia
- How many people
- 161 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Mar 2014to 3 Jul 2019
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- Foreign language spoken at home with both parents
- Known hearing deficit
- Invalid social security
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitzlier Le Vinatier
Bron, 69500
Service ORL CHU Montpied
Clermont-Ferrand, 63003
Service d'Audiologie et Explorations Orofaciales Centre de Référence des Troubles des Apprentissages
Lyon
About this study
Official title: 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.
- Conditions
- Dyslexia
- Being tested
- no intervention
- Keywords
- Dyslexia, Medial olivocochlear system, Maturation, Auditory Processing
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Dyslexic children | Longitudinal follow-up without intervention Receives: Other: no intervention | |
| Normal reading children | Longitudinal follow-up without intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 and then at least 2 years (± 4 weeks)
Secondary outcomes (3)
Change in the level of reading skill
Behavioral measure
Measured: 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.
Oral repetition of VCV
Measured: 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)
Presentation of different speech material to both ears simultaneously
Measured: Day 1 and then at least 2 years (± 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start11 Mar 2014
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345876
- Sponsor's protocol ID
- 2013-799
- Acronym
- ASTRAUCOLE
- Status last verified
- Jul 2019
- First submitted
- 9 Dec 2014
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymmetry, Auditory Processing and Reading Skills in Phonological Dyslexic Children Compared to Average-reading Children
- ClinicalTrials.gov ID
- NCT02345876
- Acronym / sponsor ID
- ASTRAUCOLE / 2013-799
- Conditions
- Dyslexia
- Keywords
- Dyslexia, Medial olivocochlear system, Maturation, Auditory Processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Mar 2014 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 26 Jan 2015 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyslexic children | – | Other: no interventionLongitudinal follow-up without intervention |
| Normal reading children | – | Other: no interventionLongitudinal follow-up without intervention |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | Dyslexic children, Normal reading children |
Primary outcome
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)
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
3 secondary outcomes
Change in the level of reading skill
Time frame: 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.
Time frame: 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)
Time frame: Day 1 and then at least 2 years (± 4 weeks)
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 18 Jul 2019.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslexia, run by Hospices Civils de Lyon at 3 sites in France.
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 0 inclusion and 9 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.