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NCT Number: NCT05624983

Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand, UMR INSERM 1107

Clermont-Ferrand, France

Location contact

Catherine SARRET

PRINCIPAL_INVESTIGATOR

Fabrice GIRAUDET

SUB_INVESTIGATOR

Lise Laclautre

CONTACT

[email protected]

04 73 75 11 95

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acoustic otoemisions

Diagnostic Test

TOAE and DPOAE

Otoscopy

Diagnostic Test

presence of earwax checked by video otoscop

audiometry

Diagnostic Test

Hearing Threshold will be measured with the AD528 interacoustics

Tympanometry

Diagnostic Test

Tympanic mobility will be measyred with the Titan interacoustics

Primary outcomes

  1. HF DPOAE measurement

    Time frame: Day 1

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

Secondary outcomes

  1. Presence or absence of HF DPOAE

    Time frame: 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.

  2. Functional status of the middle ear

    Time frame: Day 1

    assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C

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

    Time frame: Day 1

    according to the BIAP, average of audiometric thresholds at 500Hz thresholds at 500Hz, 1kHz, 2kHz and 4kHz

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

    Time frame: 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.

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

    Time frame: day 1

    assessment and scoring by speech and language therapists

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

04 73 75 11 95

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: OTOEMHF

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 22, 2022
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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