Language ImpairmentPRODIPRICIDENCT02574299
Characterization of Auditory Processing Involved in the Encoding of Speech Sounds
A study testing E-learning and Hearing aids fitting in people with Language Impairment and Hearing Loss, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The ability to encode the speech signal is determined by ascending and descending auditory processing. Difficulties in processing these speech signals are well described at the behavioral level in a specific language disorder. However, little is known about the underlying pathophysiological mechanisms. Read more about this study
- Who is it for?
- Ages 6 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Language Impairment, Hearing Loss
- What is being tested?
- E-learning and Hearing aids fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2014to 1 Mar 2018
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For all subjects:
- native French speaker
- no medical treatment for behavior or neurological disorders
- normal or corrected vision
- right-handed
- normal otorhinolaryngology examination
Show all 25Show fewer
- valid affiliation to social security
- no participation to another research study
- For the normal-hearing subjects
- normal tonal hearing thresholds
- normal tympanometry
- For the subjects without specific language impairment
- aged from 6 ro 40
- normal school attendance without scholastic retardation
- normal intellectual level
- normal for age reading skills
- no delayed speech (expression \& production)
- For the children with specific language impairment
- aged fom 8 to 18
- persistent specific literacy difficulties with reading levels at least 18 months behind that of their peers
- normal intellectual level
- For the hearing impaired subjects
- age from 18 to 70
- first auditory rehabilitation
- bilateral and symmetric hearing loss (±10 dB) with hearing thresholds between 0 and 25 dB at 0.25 kilohertz, 0 and 35 dB at 0.5 kilohertz, 0 and 50 dB at 1 kilohertz, 25 and 70 dB at 2 kilohertz, 25 and 80 dB at 3 kilohertz, 30 and 80 dB at 4 kilohertz
Who cannot join
- non signed assent
- treatment for depression, epilepsy, Parkinson's or alzheimer's disease during more than 6 months
- physical health deficiency
- mental retardation
- neurological or psychiatric disease incompatible with testing procedure
- For children
Show all 9Show fewer
- known problem of hearing loss or chronic middle ear disease whic compromized the hearing status
- schooling in a foreign language
- foreign language spoken at home with both parents
Trial locations and contacts
1 site in 1 country.
France1 site
Sercive d'Audiologie et d'Exploration Orofaciales, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69003
About this study
Official title: Characterization of Ascending and Descending Auditory Processing Involved in the Encoding of Speech Sounds in Adult and Children: Variability Related to Changes in Sensory Input or a Neurodevelopmental Disorder or Targeted Remediation
The ability to encode the speech signal is determined by ascending and descending auditory processing. Difficulties in processing these speech signals are well described at the behavioral level in a specific language disorder. However, little is known about the underlying pathophysiological mechanisms. The assumption is that we should observe a degradation of the signal provided by the ear in the deaf subject while in case of specific language impairment it would be a phonemic disorder (possibly linked to a processing disorder auditory). The two population groups should therefore have different abnormalities of their central auditory process - which could be modified by the target remediation for each group.
- Conditions
- Language Impairment, Hearing Loss
- Being tested
- E-learning, Hearing aids fitting
- Keywords
- dyslexia, training, auditory rehabilitation, hearing loss, evoked potentials, dichotic, plasticity, noise
- Medical subject headings
- Language Disorders, Hearing Loss, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learningOther
Management of auditory processing disorders with serious game (E-learning)
Hearing aids fittingDevice
Symmetrical hearing loss which are fitted with binaural hearing aids for the first time
| Study group | Role | What they receive |
|---|---|---|
| 1: Normal hearing children without SLI, transversal group | No intervention | Normal hearing children without Specific Language Impairment (SLI),Transversal group for test-retest measures |
| 2: Normal hearing children without SLI, longitudinal group | No intervention | Normal hearing children without Specific Language Impairment (SLI), longitudinal group without training |
| 3: Normal hearing children with SLI, longitudinal group | Other | Normal hearing children with Specific Language Impairment (SLI), longitudinal group with training Receives: Other: E-learning |
| 4: Normal hearing adults without SLI, transversal group | No intervention | Normal hearing adults without Specific Language Impairment (SLI), transversal group for test-retest measures |
| 5: Normal hearing adults without SLI, longitudinal group | No intervention | Normal hearing adults without Specific Language Impairment (SLI), longitudinal group without hearing aids (HA) |
| 6: Hearing Impaired candidates for HA, longitudinal group | Other | Hearing Impaired adult candidates for hearing aids (HA), longitudinal group with hearing aids (HA) Receives: Device: Hearing aids fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline speech auditory brainstem and late responses (composite and objective measure) in response to syllables (behavioral measure)
Spectro-temporal analysis of speech auditory brainstem and late responses : The speech brainstem and cortical responses are simultaneously obtained in response of different selected syllables from a continuum (selected by using a phonemic identification test) which is presented throughout a behavioral categorical procedure
Measured: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline
Secondary outcomes (3)
Change from Baseline medial olivocochlear system (MOCS) functioning measured using the contralateral suppressive effect of transient evoked otoacoustic emissions (composite measure)
Measurement of the contralateral suppressive effect of transient evoked otoacoustic emissions (expressed as Equivalent Attenuation)
Measured: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline
Change from Baseline dichotic skills measured using central auditory processing tests (composite measure)
Presentation of different speech material to both ears simultaneously
Measured: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline
Change from Baseline speech-noise listening skills measured using logatomes tests (composite measure)
Presentation of disyllabic words in presence of increasing noise levels
Measured: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start16 Oct 2014
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
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 Language ImpairmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT02574299
- Sponsor's protocol ID
- 2013-796
- Other IDs
- ID-RCB
- Acronym
- PRODIPRICIDE
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Reynard P, Veuillet E, Thai-Van H. Paradoxical and labile medial olivocochlear functioning as a potential marker of auditory processing disorder in a child with learning disabilities. Eur Ann Otorhinolaryngol Head Neck Dis. 2020 Sep;137(4):339-342. doi: 10.1016/j.anorl.2020.03.005. Epub 2020 Apr 1.
PubMed 32247718Bellier L, Bouchet P, Jeanvoine A, Valentin O, Thai-Van H, Caclin A. Topographic recordings of auditory evoked potentials to speech: subcortical and cortical responses. Psychophysiology. 2015 Apr;52(4):594-9. doi: 10.1111/psyp.12369. Epub 2014 Oct 20.
PubMed 25329609Bellier L, Veuillet E, Vesson JF, Bouchet P, Caclin A, Thai-Van H. Speech Auditory Brainstem Response through hearing aid stimulation. Hear Res. 2015 Jul;325:49-54. doi: 10.1016/j.heares.2015.03.004. Epub 2015 Mar 27.
PubMed 25828076
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Ascending and Descending Auditory Processing Involved in the Encoding of Speech Sounds in Adult and Children: Variability Related to Changes in Sensory Input or a Neurodevelopmental Disorder or Targeted Remediation
- ClinicalTrials.gov ID
- NCT02574299
- Acronym / sponsor ID
- PRODIPRICIDE / 2013-796
- Conditions
- Language Impairment, Hearing Loss
- Keywords
- dyslexia, training, auditory rehabilitation, hearing loss, evoked potentials, dichotic, plasticity, noise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Oct 2014
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 12 Oct 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 ability to encode the speech signal is determined by ascending and descending auditory processing. Difficulties in processing these speech signals are well described at the behavioral level in a specific language disorder. However, little is known about the underlying pathophysiological mechanisms. The assumption is that we should observe a degradation of the signal provided by the ear in the deaf subject while in case of specific language impairment it would be a phonemic disorder (possibly linked to a processing disorder auditory). The two population groups should therefore have different abnormalities of their central auditory process - which could be modified by the target remediation for each group.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1: Normal hearing children without SLI, transversal group | No intervention | –Normal hearing children without Specific Language Impairment (SLI),Transversal group for test-retest measures |
| 2: Normal hearing children without SLI, longitudinal group | No intervention | –Normal hearing children without Specific Language Impairment (SLI), longitudinal group without training |
| 3: Normal hearing children with SLI, longitudinal group | Other | Other: E-learningNormal hearing children with Specific Language Impairment (SLI), longitudinal group with training |
| 4: Normal hearing adults without SLI, transversal group | No intervention | –Normal hearing adults without Specific Language Impairment (SLI), transversal group for test-retest measures |
| 5: Normal hearing adults without SLI, longitudinal group | No intervention | –Normal hearing adults without Specific Language Impairment (SLI), longitudinal group without hearing aids (HA) |
| 6: Hearing Impaired candidates for HA, longitudinal group | Other | Device: Hearing aids fittingHearing Impaired adult candidates for hearing aids (HA), longitudinal group with hearing aids (HA) |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- native French speaker
- no medical treatment for behavior or neurological disorders
- normal or corrected vision
- right-handed
- normal otorhinolaryngology examination
Key exclusion criteria (9 listed)
- non signed assent
- treatment for depression, epilepsy, Parkinson's or alzheimer's disease during more than 6 months
- physical health deficiency
- mental retardation
- neurological or psychiatric disease incompatible with testing procedure
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 |
|---|---|---|
| E-learningManagement of auditory processing disorders with serious game (E-learning) | Other | 3: Normal hearing children with SLI, longitudinal group |
| Hearing aids fittingSymmetrical hearing loss which are fitted with binaural hearing aids for the first time | Device | 6: Hearing Impaired candidates for HA, longitudinal group |
Primary outcome
Change from Baseline speech auditory brainstem and late responses (composite and objective measure) in response to syllables (behavioral measure)
Time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline
Spectro-temporal analysis of speech auditory brainstem and late responses : The speech brainstem and cortical responses are simultaneously obtained in response of different selected syllables from a continuum (selected by using a phonemic identification test) which is presented throughout a behavioral categorical procedure
3 secondary outcomes
Change from Baseline medial olivocochlear system (MOCS) functioning measured using the contralateral suppressive effect of transient evoked otoacoustic emissions (composite measure)
Time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline
Change from Baseline dichotic skills measured using central auditory processing tests (composite measure)
Time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline
Change from Baseline speech-noise listening skills measured using logatomes tests (composite measure)
Time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline
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 19 Dec 2025.
- Results publication: PubMed 32247718Reynard P, Veuillet E, Thai-Van H. Paradoxical and labile medial olivocochlear functioning as a potential marker of auditory processing disorder in a child with learning disabilities. Eur Ann Otorhinolaryngol Head Neck Dis. 2020 Sep;137(4):339-342. doi: 10.1016/j.anorl.2020.03.005. Epub 2020 Apr 1.
- Results publication: PubMed 25329609Bellier L, Bouchet P, Jeanvoine A, Valentin O, Thai-Van H, Caclin A. Topographic recordings of auditory evoked potentials to speech: subcortical and cortical responses. Psychophysiology. 2015 Apr;52(4):594-9. doi: 10.1111/psyp.12369. Epub 2014 Oct 20.
- Results publication: PubMed 25828076Bellier L, Veuillet E, Vesson JF, Bouchet P, Caclin A, Thai-Van H. Speech Auditory Brainstem Response through hearing aid stimulation. Hear Res. 2015 Jul;325:49-54. doi: 10.1016/j.heares.2015.03.004. Epub 2015 Mar 27.
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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?
A study testing E-learning and Hearing aids fitting in people with Language Impairment and Hearing Loss, run by Hospices Civils de Lyon at 1 site 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 25 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 19 Dec 2025. 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 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 from Baseline speech auditory brainstem and late responses (composite and objective measure) in response to syllables (behavioral measure) (time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574299, 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 19 Dec 2025.