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CompletedNCT02574299PRODIPRICIDEUpdated Dec 19, 2025

Characterization of Auditory Processing Involved in the Encoding of Speech Sounds

An interventional study of E-learning and Hearing aids fitting in Language Impairment and Hearing Loss, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 6 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
6 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Language Impairment
  • Hearing Loss

Keywords

  • dyslexia
  • training
  • auditory rehabilitation
  • hearing loss
  • evoked potentials
  • dichotic
  • plasticity
  • noise
03

In context

Language Disorders

84 studies on the registry are indexed under Language Disorders; 18 are open to participants now.

This study's enrollment of 25 is below the median of 51 across 66 interventional studies indexed under Language Disorders.

Browse Language Disorders studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For all subjects:

  • native French speaker
  • no medical treatment for behavior or neurological disorders
  • normal or corrected vision
  • right-handed
  • normal otorhinolaryngology examination
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • No intervention
    1: Normal hearing children without SLI, transversal group

    Normal hearing children without Specific Language Impairment (SLI),Transversal group for test-retest measures

  • No intervention
    2: Normal hearing children without SLI, longitudinal group

    Normal hearing children without Specific Language Impairment (SLI), longitudinal group without training

  • Other
    3: Normal hearing children with SLI, longitudinal group

    Normal hearing children with Specific Language Impairment (SLI), longitudinal group with training

    Other: E-learning

  • No intervention
    4: Normal hearing adults without SLI, transversal group

    Normal hearing adults without Specific Language Impairment (SLI), transversal group for test-retest measures

  • No intervention
    5: Normal hearing adults without SLI, longitudinal group

    Normal hearing adults without Specific Language Impairment (SLI), longitudinal group without hearing aids (HA)

  • Other
    6: Hearing Impaired candidates for HA, longitudinal group

    Hearing Impaired adult candidates for hearing aids (HA), longitudinal group with hearing aids (HA)

    Device: Hearing aids fitting

Interventions

  • OtherE-learning

    Management of auditory processing disorders with serious game (E-learning)

  • DeviceHearing aids fitting

    Symmetrical hearing loss which are fitted with binaural hearing aids for the first time

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline

Secondary outcomes

  1. 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)

    Time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline

  2. Change from Baseline dichotic skills measured using central auditory processing tests (composite measure)

    Presentation of different speech material to both ears simultaneously

    Time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline

  3. Change from Baseline speech-noise listening skills measured using logatomes tests (composite measure)

    Presentation of disyllabic words in presence of increasing noise levels

    Time frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline

07

Study locations

1 site
  • Sercive d'Audiologie et d'Exploration Orofaciales, Hôpital Edouard Herriot, Hospices Civils de Lyon
    Lyon, 69003, France
08

References and documents

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 32247718 ↗
  • Bellier 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 25329609 ↗
  • Bellier 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Mar 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2015
First posted
Oct 12, 2015
Start
Oct 16, 2014
Primary completionActual
Mar 1, 2018
CompletionActual
Mar 1, 2018
Last update
Dec 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02574299
Responsible party
Sponsor
First posted
Oct 12, 2015
Start date
Oct 16, 2014
Primary completion
Mar 1, 2018
Completion
Mar 1, 2018
Last update
Dec 19, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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