An interventional study of acoustic otoemisions and Otoscopy in Language Development Disorders, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-22.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
Among the objective non-invasive audiological explorations the distorsion products of otoacoustic emissions (DPOAE) allow to quickly assess the function of the cochlear outer hair cells (without the active participation of the subject). This technique is used in newborn screening. While humans are able to perceive sounds in a frequency range of 20Hz to 20kHz, routine clinical audiological assessment is only concerned with frequencies between 1-4kHz.
This obscures the importance of high frequencies (HF) which can be easily assessed by DPOAEs. In young children, the perception of these high frequencies could also play an important role in language acquisition.
The main objective of this study is to evaluate the relationship between subtle high-frequency hearing impairment, as assessed by the DPOAE (non-invasive, rapid and simple audiological test), and language delay or difficulties in a pre-, peri- and school-age pediatric population.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 138 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for case (children with language disorder):
Inclusion Criteria for control (children without language disorder) :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hearing diagnostic test
Diagnostic Test: acoustic otoemisions · Diagnostic Test: Otoscopy · Diagnostic Test: Audiometry · Diagnostic Test: Tympanometry
Hearing diagnostic test
Diagnostic Test: acoustic otoemisions · Diagnostic Test: Otoscopy · Diagnostic Test: Audiometry · Diagnostic Test: Tympanometry
TOAE and DPOAE
presence of earwax checked by video otoscop
Hearing Threshold will be measured with the AD528 interacoustics
Tympanic mobility will be measyred with the Titan interacoustics
HF DPOAE measurement
at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz
Time frame: Day 1
Presence or absence of HF DPOAE
assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C frequency will be defined by a signal to noise ratio \> 6 dB. The absence of DPOAE for each frequency will be defined by a signal to noise ratio ≤ 6 dB.
Time frame: Day 1
Functional status of the middle ear
assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C
Time frame: Day 1
Determination of the average hearing loss (baseline pure tone audiometry)
according to the BIAP, average of audiometric thresholds at 500Hz thresholds at 500Hz, 1kHz, 2kHz and 4kHz
Time frame: Day 1
Laterality of hearing loss at the DPOAE level with a classification into 3 groups
Not affected bilaterally affected, unilateral affected, bilateral affected; one side is considered to be affected if at least one of the at least one of the HF DPOAEs is ≤ 6 dB.
Time frame: Day 1
Severity and type of language impairment assessed by the EVALO/ EVALEO
assessment and scoring by speech and language therapists
Time frame: day 1
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Language Development Disorders →
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