Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

Language Development Disorders Clinical Trial

— OTOEMHF  

Official title:

Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05624983
• Other study ID #: RBHP 2022 SARRET
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 1, 2027

Study information

• Verified date: September 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 04 73 75 11 95
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Language Development Disorders
• Language Disorders

Intervention

Diagnostic Test:
• acoustic otoemisions
TOAE and DPOAE
• Otoscopy
presence of earwax checked by video otoscop
• Audiometry
Hearing Threshold will be measured with the AD528 interacoustics
• Tympanometry
Tympanic mobility will be measyred with the Titan interacoustics

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand, UMR INSERM 1107	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HF DPOAE measurement	at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz	Day 1
Secondary	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
Secondary	Functional status of the middle ear	assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C	Day 1
Secondary	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
Secondary	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
Secondary	Severity and type of language impairment assessed by the EVALO/ EVALEO	assessment and scoring by speech and language therapists	day 1