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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02574299
Other study ID # 2013-796
Secondary ID ID-RCB
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2014
Est. completion date March 1, 2018

Study information

Verified date February 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
E-learning
Management of auditory processing disorders with serious game (E-learning)
Device:
Hearing aids fitting
Symmetrical hearing loss which are fitted with binaural hearing aids for the first time

Locations

Country Name City State
France Sercive d'Audiologie et d'Exploration Orofaciales, Hôpital Edouard Herriot, Hospices Civils de Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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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