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Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05624983
Acronym
OTOEMHF
Enrollment
138
Registered
2022-11-22
Start date
2023-01-01
Completion date
2027-07-01
Last updated
2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Language Development Disorders

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTOtoscopy

presence of earwax checked by video otoscop

DIAGNOSTIC_TESTacoustic otoemisions

TOAE and DPOAE

DIAGNOSTIC_TESTAudiometry

Hearing Threshold will be measured with the AD528 interacoustics

DIAGNOSTIC_TESTTympanometry

Tympanic mobility will be measyred with the Titan interacoustics

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
HF DPOAE measurementDay 1at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz

Secondary

MeasureTime frameDescription
Presence or absence of HF DPOAEDay 1assessed 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.
Functional status of the middle earDay 1assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C
Determination of the average hearing loss (baseline pure tone audiometry)Day 1according to the BIAP, average of audiometric thresholds at 500Hz thresholds at 500Hz, 1kHz, 2kHz and 4kHz
Laterality of hearing loss at the DPOAE level with a classification into 3 groupsDay 1Not 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.
Severity and type of language impairment assessed by the EVALO/ EVALEOday 1assessment and scoring by speech and language therapists

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026