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Clinical Trials/NCT05624983
NCT05624983
Not yet recruiting
Not Applicable

Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

University Hospital, Clermont-Ferrand1 site in 1 country138 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Language Development Disorders
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
138
Locations
1
Primary Endpoint
HF DPOAE measurement
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
July 1, 2027
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

HF DPOAE measurement

Time Frame: Day 1

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

Secondary Outcomes

  • Presence or absence of HF DPOAE(Day 1)
  • Laterality of hearing loss at the DPOAE level with a classification into 3 groups(Day 1)
  • Determination of the average hearing loss (baseline pure tone audiometry)(Day 1)
  • Severity and type of language impairment assessed by the EVALO/ EVALEO(day 1)
  • Functional status of the middle ear(Day 1)

Study Sites (1)

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