Clinical trial NCT05624983: Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders
Official title: Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Language Development Disorders
Keywords: Language development disorders
otoemisions
child
high frequencies
hearing
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 138
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group of cases (children with language disorder) one group of control (children without language disorder)
Primary purpose: DIAGNOSTIC

Brief summary: 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.


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

Primary outcomes:
measure: HF DPOAE measurement
timeFrame: Day 1
Secondary outcomes:
measure: Presence or absence of HF DPOAE
timeFrame: Day 1
measure: Functional status of the middle ear
timeFrame: Day 1
measure: Determination of the average hearing loss (baseline pure tone audiometry)
timeFrame: Day 1
measure: Laterality of hearing loss at the DPOAE level with a classification into 3 groups
timeFrame: Day 1
measure: Severity and type of language impairment assessed by the EVALO/ EVALEO
timeFrame: day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand, UMR INSERM 1107
Study officials:
References: