Characterization of Auditory Processing Involved in the Encoding of Speech Sounds (NCT02574299) | Clinical Trial Compass
CompletedNot Applicable
Characterization of Auditory Processing Involved in the Encoding of Speech Sounds
France25 participantsStarted 2014-10-16
Plain-language 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.
Who can participate
Age range
6 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 chroni…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline speech auditory brainstem and late responses (composite and objective measure) in response to syllables (behavioral measure)
Timeframe: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline