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

Primary Purpose

Language Development Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
acoustic otoemisions
Otoscopy
Audiometry
Tympanometry
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Language Development Disorders focused on measuring Language development disorders, otoemisions, child, high frequencies, hearing

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand, UMR INSERM 1107

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Case group (children with language disorder)

controle group (children without language disorder)

Arm Description

Hearing diagnostic test

Hearing diagnostic test

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Functional status of the middle ear
assessed 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)
according 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 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.
Severity and type of language impairment assessed by the EVALO/ EVALEO
assessment and scoring by speech and language therapists

Full Information

First Posted
November 2, 2022
Last Updated
November 21, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05624983
Brief Title
Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders
Acronym
OTOEMHF
Official Title
Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development Disorders
Keywords
Language development disorders, otoemisions, child, high frequencies, hearing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one group of cases (children with language disorder) one group of control (children without language disorder)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case group (children with language disorder)
Arm Type
Experimental
Arm Description
Hearing diagnostic test
Arm Title
controle group (children without language disorder)
Arm Type
Other
Arm Description
Hearing diagnostic test
Intervention Type
Diagnostic Test
Intervention Name(s)
acoustic otoemisions
Intervention Description
TOAE and DPOAE
Intervention Type
Diagnostic Test
Intervention Name(s)
Otoscopy
Intervention Description
presence of earwax checked by video otoscop
Intervention Type
Diagnostic Test
Intervention Name(s)
Audiometry
Intervention Description
Hearing Threshold will be measured with the AD528 interacoustics
Intervention Type
Diagnostic Test
Intervention Name(s)
Tympanometry
Intervention Description
Tympanic mobility will be measyred with the Titan interacoustics
Primary Outcome Measure Information:
Title
HF DPOAE measurement
Description
at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Presence or absence of HF DPOAE
Description
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.
Time Frame
Day 1
Title
Functional status of the middle ear
Description
assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C
Time Frame
Day 1
Title
Determination of the average hearing loss (baseline pure tone audiometry)
Description
according to the BIAP, average of audiometric thresholds at 500Hz thresholds at 500Hz, 1kHz, 2kHz and 4kHz
Time Frame
Day 1
Title
Laterality of hearing loss at the DPOAE level with a classification into 3 groups
Description
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.
Time Frame
Day 1
Title
Severity and type of language impairment assessed by the EVALO/ EVALEO
Description
assessment and scoring by speech and language therapists
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
04 73 75 11 95
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU Clermont-Ferrand, UMR INSERM 1107
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
04 73 75 11 95
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Catherine SARRET
First Name & Middle Initial & Last Name & Degree
Fabrice GIRAUDET

12. IPD Sharing Statement

Plan to Share IPD
No

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Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

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