NCT02574299

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3.4 years

First QC Date

August 14, 2015

Last Update Submit

December 13, 2025

Conditions

Keywords

dyslexiatrainingauditory rehabilitationhearing lossevoked potentialsdichoticplasticitynoise

Outcome Measures

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

    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)

    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)

    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)

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

Study Arms (6)

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

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)

Device: Hearing aids fitting

Interventions

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

3: Normal hearing children with SLI, longitudinal group

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

6: Hearing Impaired candidates for HA, longitudinal group

Eligibility Criteria

Age6 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +10 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sercive d'Audiologie et d'Exploration Orofaciales, Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, 69003, France

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Language DisordersHearing LossDyslexia

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersSpecific Learning DisorderLearning DisabilitiesNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2015

First Posted

October 12, 2015

Study Start

October 16, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations