Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: acoustic otoemisions, Otoscopy, Audiometry, Tympanometry.
- Who it may be relevant to
- Registry conditions: Language Development Disorders. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test acoustic otoemisions
TOAE and DPOAE - Diagnostic test Otoscopy
presence of earwax checked by video otoscop - Diagnostic test Audiometry
Hearing Threshold will be measured with the AD528 interacoustics - Diagnostic test Tympanometry
Tympanic mobility will be measyred with the Titan interacoustics
Primary outcome measures
- HF DPOAE measurement [Time frame: Day 1]
Secondary outcome measures (5)
- Presence or absence of HF DPOAE [Time frame: Day 1]
- Functional status of the middle ear [Time frame: Day 1]
- Determination of the average hearing loss (baseline pure tone audiometry) [Time frame: Day 1]
- Laterality of hearing loss at the DPOAE level with a classification into 3 groups [Time frame: Day 1]
- Severity and type of language impairment assessed by the EVALO/ EVALEO [Time frame: day 1]
Eligibility criteria
Inclusion Criteria for case (children with language disorder):
- Normal hearing (after an audiometry test, even if an ENT consultation has been carried out beforehand and if the doctor has not found any hearing problem, as defined in the NF EN ISO 70292017-04 standard, and according to an average hearing loss calculated according to the BIAP <20dB HL)
- Free and informed consent of the parental authority and the patient
- Affiliated to the social security system
- Presenting a developmental language acquisition disorder (score according to the EVALO / EVALEO test)
- For children between 15 and 17 years of age, completion of the EVALEO test before their 16th birthday
Inclusion Criteria for control (children without language disorder) :
- Normal hearing (after an audiometry test, even if an ENT consultation has been performed beforehand and if the doctor has not found any hearing problem, as defined in the NF EN ISO 70292017-04 standard, and according to an average hearing loss calculated according to the BIAP <20dB HL)
- Free and informed consent of the parental authority and the patient
- Enrolled in the social security system
Exclusion criteria
- Hearing disorder identified during the inclusion visit (presence of cerumen or foreign body in the earwax plug or foreign body in the external auditory canal, tympanometry suggesting a middle ear disorder, audiometry with thresholds outside the normal thresholds outside the normal range (0-20dB HL), absence of responses in (0-20dB HL), absence of responses in acoustic otoemissions or acoustic distortion products) on conversational frequencies between 500Hz and 4kHz.
- Declaration by the parents of an ENT follow-up for a hearing disorder and/or a speech therapy for a language disorder
- Refusal of participation evoked by the subject
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHU Clermont-Ferrand, UMR INSERM 1107 — Clermont-Ferrand
Identifiers
NCT: NCT05624983 · RBHP 2022 SARRET