Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

NCT05624983 | Not Yet Recruiting

• 1 other identifier: RBHP 2022 SARRET
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Language Development Disorders

Keywords

Language development disorders; otoemisions; child; high frequencies; hearing

Outcome Measures

Primary Outcomes (1)

• HF DPOAE measurement

  at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz

  Day 1

Secondary Outcomes (5)

• Presence or absence of HF DPOAE

  Day 1

• Functional status of the middle ear

  Day 1

• Determination of the average hearing loss (baseline pure tone audiometry)

  Day 1

• Laterality of hearing loss at the DPOAE level with a classification into 3 groups

  Day 1

• Severity and type of language impairment assessed by the EVALO/ EVALEO

  day 1

Study Arms (2)

Case group (children with language disorder)

EXPERIMENTAL

Hearing diagnostic test

Diagnostic Test: acoustic otoemisions; Diagnostic Test: Otoscopy; Diagnostic Test: Audiometry; Diagnostic Test: Tympanometry

controle group (children without language disorder)

OTHER

Hearing diagnostic test

Diagnostic Test: acoustic otoemisions; Diagnostic Test: Otoscopy; Diagnostic Test: Audiometry; Diagnostic Test: Tympanometry

Interventions

acoustic otoemisions DIAGNOSTIC_TEST

TOAE and DPOAE

Case group (children with language disorder); controle group (children without language disorder)

Otoscopy DIAGNOSTIC_TEST

presence of earwax checked by video otoscop

Case group (children with language disorder); controle group (children without language disorder)

Audiometry DIAGNOSTIC_TEST

Hearing Threshold will be measured with the AD528 interacoustics

Case group (children with language disorder); controle group (children without language disorder)

Tympanometry DIAGNOSTIC_TEST

Tympanic mobility will be measyred with the Titan interacoustics

Case group (children with language disorder); controle group (children without language disorder)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand, UMR INSERM 1107

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Language Development Disorders

Interventions

Otoscopy; Audiometry; Acoustic Impedance Tests

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis; Hearing Tests

Central Study Contacts

Lise Laclautre

CONTACT

04 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group of cases (children with language disorder) one group of control (children without language disorder)

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 22, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)