Hearing Loss Clinical Trial
— PRODIPRICIDEOfficial 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
Verified date | February 2021 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Sercive d'Audiologie et d'Exploration Orofaciales, Hôpital Edouard Herriot, Hospices Civils de Lyon | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline | |
Secondary | Change from Baseline dichotic skills measured using central auditory processing tests (composite measure) | Presentation of different speech material to both ears simultaneously | Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline | |
Secondary | Change from Baseline speech-noise listening skills measured using logatomes tests (composite measure) | Presentation of disyllabic words in presence of increasing noise levels | Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline |
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