Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders (OTOEMHF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Language Development Disorders
• Intervention / Treatment: Diagnostic test: acoustic otoemisions; Diagnostic test: Otoscopy; Diagnostic test: Audiometry; Diagnostic test: Tympanometry

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand, UMR INSERM 1107
    • Sub-Investigator: Fabrice GIRAUDET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group (children with language disorder); Hearing diagnostic test	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
Other: controle group (children without language disorder); Hearing diagnostic test	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HF DPOAE measurement	at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
Functional status of the middle ear	assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C	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	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.	Day 1
Severity and type of language impairment assessed by the EVALO/ EVALEO	assessment and scoring by speech and language therapists	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): July 1, 2027
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: child; hearing; Language development disorders; otoemisions; high frequencies
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Disease; Language Disorders; Language Development Disorders
• Other Study ID Numbers: RBHP 2022 SARRET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No