Language Development DisordersOTOEMHFNCT05624983
Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders
A study testing acoustic otoemisions, Otoscopy and Audiometry in people with Language Development Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Language Development Disorders
- What is being tested?
- acoustic otoemisions, Otoscopy and Audiometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand, UMR INSERM 1107
Clermont-Ferrand
Lise Laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
Catherine SARRET
About this study
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.
- Conditions
- Language Development Disorders
- Being tested
- acoustic otoemisions, Otoscopy, Audiometry, Tympanometry
- Keywords
- Language development disorders, otoemisions, child, high frequencies, hearing
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoustic otoemisionsDiagnostic test
TOAE and DPOAE
OtoscopyDiagnostic test
presence of earwax checked by video otoscop
AudiometryDiagnostic test
Hearing Threshold will be measured with the AD528 interacoustics
TympanometryDiagnostic test
Tympanic mobility will be measyred with the Titan interacoustics
| Study group | Role | What they receive |
|---|---|---|
| Case group (children with language disorder) | Experimental | Hearing diagnostic test Receives: Diagnostic Test: acoustic otoemisions; Diagnostic Test: Otoscopy; Diagnostic Test: Audiometry; Diagnostic Test: Tympanometry |
| controle group (children without language disorder) | Other | Hearing diagnostic test Receives: Diagnostic Test: acoustic otoemisions; Diagnostic Test: Otoscopy; Diagnostic Test: Audiometry; Diagnostic Test: Tympanometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF DPOAE measurement
at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz
Measured: Day 1
Secondary outcomes (5)
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.
Measured: Day 1
Functional status of the middle ear
assessed by tympanometry, categorisation of this categorisation of this into 3 classes A, B and C
Measured: Day 1
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
Measured: Day 1
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.
Measured: Day 1
Severity and type of language impairment assessed by the EVALO/ EVALEO
assessment and scoring by speech and language therapists
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- one group of cases (children with language disorder) one group of control (children without language disorder)
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624983
- Sponsor's protocol ID
- RBHP 2022 SARRET
- Acronym
- OTOEMHF
- Status last verified
- Sep 2022
- First submitted
- 2 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No