CHU Clermont-Ferrand, UMR INSERM 1107
Clermont-Ferrand, France
Location contact
Catherine SARRET
PRINCIPAL_INVESTIGATOR
Fabrice GIRAUDET
SUB_INVESTIGATOR
Lise Laclautre
CONTACT
NCT Number: NCT05624983
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.
Trial opening soon.
Get Notified2 year–17 year
All sexes
Interventional
Not applicable
Clermont-Ferrand, France
Catherine SARRET
PRINCIPAL_INVESTIGATOR
Fabrice GIRAUDET
SUB_INVESTIGATOR
Lise Laclautre
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for case (children with language disorder):
Inclusion criteria
for control (children without language disorder) :
Exclusion criteria
TOAE and DPOAE
presence of earwax checked by video otoscop
Hearing Threshold will be measured with the AD528 interacoustics
Tympanic mobility will be measyred with the Titan interacoustics
Time frame: Day 1
at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz
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.
Time frame: Day 1
assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C
Time frame: Day 1
according to the BIAP, average of audiometric thresholds at 500Hz thresholds at 500Hz, 1kHz, 2kHz and 4kHz
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.
Time frame: day 1
assessment and scoring by speech and language therapists
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
Acronym: OTOEMHF
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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