Characterization of Auditory Processing Involved in the Encoding of Speech Sounds

Hearing Loss Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574299
• Other study ID #: 2013-796
• Secondary ID: ID-RCB
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Language Disorders
• Language Impairment

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