Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

Not Applicable

Not yet recruiting

• Conditions: Language Development Disorders
• Interventions: Diagnostic Test: acoustic otoemisions; Diagnostic Test: Otoscopy; Diagnostic Test: Audiometry; Diagnostic Test: Tympanometry

• Registration Number: NCT05624983
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Study Start: 2023-01-01
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case group (children with language disorder)	acoustic otoemisions	Hearing diagnostic test
Case group (children with language disorder)	Otoscopy	Hearing diagnostic test
controle group (children without language disorder)	acoustic otoemisions	Hearing diagnostic test
controle group (children without language disorder)	Tympanometry	Hearing diagnostic test
Case group (children with language disorder)	Tympanometry	Hearing diagnostic test
controle group (children without language disorder)	Otoscopy	Hearing diagnostic test
controle group (children without language disorder)	Audiometry	Hearing diagnostic test
Case group (children with language disorder)	Audiometry	Hearing diagnostic test

Primary Outcome Measures

Name	Time	Method
HF DPOAE measurement	Day 1	at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz

Secondary Outcome Measures

Name	Time	Method
Presence or absence of HF DPOAE	Day 1	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.
Laterality of hearing loss at the DPOAE level with a classification into 3 groups	Day 1	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.
Determination of the average hearing loss (baseline pure tone audiometry)	Day 1	according to the BIAP, average of audiometric thresholds at 500Hz thresholds at 500Hz, 1kHz, 2kHz and 4kHz
Severity and type of language impairment assessed by the EVALO/ EVALEO	day 1	assessment and scoring by speech and language therapists
Functional status of the middle ear	Day 1	assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C

Trial Locations

Locations (1)

CHU Clermont-Ferrand, UMR INSERM 1107; 🇫🇷 Clermont-Ferrand, France