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Characterization of Auditory Processing Involved in the Encoding of Speech Sounds (PRODIPRICIDE)

Primary Purpose

Language Impairment, Hearing Loss

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

E-learning

Hearing aids fitting

About this trial

This is an interventional basic science trial for Language Impairment focused on measuring dyslexia, training, auditory rehabilitation, hearing loss, evoked potentials, dichotic, plasticity, noise

Eligibility Criteria

6 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Other

No Intervention

Other

Arm Label

1: Normal hearing children without SLI, transversal group

2: Normal hearing children without SLI, longitudinal group

3: Normal hearing children with SLI, longitudinal group

4: Normal hearing adults without SLI, transversal group

5: Normal hearing adults without SLI, longitudinal group

6: Hearing Impaired candidates for HA, longitudinal group

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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

Presentation of different speech material to both ears simultaneously

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

Presentation of disyllabic words in presence of increasing noise levels

Full Information

NCT ID

NCT02574299

First Posted

August 14, 2015

Last Updated

February 22, 2021

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT02574299

Brief Title

Characterization of Auditory Processing Involved in the Encoding of Speech Sounds

Acronym

PRODIPRICIDE

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

October 16, 2014 (undefined)

Primary Completion Date

March 1, 2018 (Actual)

Study Completion Date

March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Language Impairment, Hearing Loss

Keywords

dyslexia, training, auditory rehabilitation, hearing loss, evoked potentials, dichotic, plasticity, noise

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1: Normal hearing children without SLI, transversal group

Arm Type

No Intervention

Arm Description

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

Arm Title

2: Normal hearing children without SLI, longitudinal group

Arm Type

No Intervention

Arm Description

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

Arm Title

3: Normal hearing children with SLI, longitudinal group

Arm Type

Other

Arm Description

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

Arm Title

4: Normal hearing adults without SLI, transversal group

Arm Type

No Intervention

Arm Description

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

Arm Title

5: Normal hearing adults without SLI, longitudinal group

Arm Type

No Intervention

Arm Description

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

Arm Title

6: Hearing Impaired candidates for HA, longitudinal group

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

E-learning

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Hearing aids fitting

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline speech auditory brainstem and late responses (composite and objective measure) in response to syllables (behavioral measure)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change from Baseline medial olivocochlear system (MOCS) functioning measured using the contralateral suppressive effect of transient evoked otoacoustic emissions (composite measure)

Description

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

Title

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

Description

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

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Facility Information:

Facility Name

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

City

Lyon

ZIP/Postal Code

69003

Country

France

12. IPD Sharing Statement

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Characterization of Auditory Processing Involved in the Encoding of Speech Sounds

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