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Completed

NCT Number: NCT02574299

Characterization of Auditory Processing Involved in the Encoding of Speech Sounds

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.

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Key information

Conditions

Language Impairment Communication Disorders Dyslexia Ear Diseases Hearing Disorders Hearing Loss Language Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Specific Learning Disorder

Age range

6 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e-learning

Other

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

Hearing aids fitting

Device

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

Primary outcomes

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

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

    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 outcomes

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

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

    Measurement of the contralateral suppressive effect of transient evoked otoacoustic emissions (expressed as Equivalent Attenuation)

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

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

    Presentation of different speech material to both ears simultaneously

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

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

    Presentation of disyllabic words in presence of increasing noise levels

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: PRODIPRICIDE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2015
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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