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Auditory Processing DisordersIRMf-TTANCT03887182

Contribution of Functional MRI in Assessment of Auditory Processing Disorders

A study testing functional MRI, Automated Cortical Brainstem Auditory Evoked Potential and whole exome sequencing in people with Auditory Processing Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Auditory Processing Disorder (APD) affects 0.5-7% of the pediatric population. This disorder is responsible for a child's low hearing ability. The diagnosis of APD is difficult because of polymorphic symptoms possibly entangled with other difficulties (learning, communication, attention ...). Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Auditory Processing Disorders
What is being tested?
functional MRI, Automated Cortical Brainstem Auditory Evoked Potential and whole exome sequencing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteFrance
Study dates
2 Sep 2020to 10 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 7 to 18 years old
  • selected following multidisciplinary consultation whether the diagnosis is confirmed (group G1) or not (group G2).
  • Signed consent of both parents
  • Affiliated with a health insurance plan
  • 7 to 18 years old
  • do not present any known hearing pathology
  • Signed consent of both parents
  • Affiliated with a health insurance plan

Who cannot join

  • Require general anesthesia for MRI
  • Contraindication to MRI
  • Hearing aids for more than three months prior to inclusion in the study
  • Require sedation specifically for research

Trial locations and contacts

1 site in 1 country.

France1 site
  • Necker Hospital

    Paris, 75015

Other trials in France

About this study

Auditory Processing Disorder (APD) affects 0.5-7% of the pediatric population. This disorder is responsible for a child's low hearing ability. The diagnosis of APD is difficult because of polymorphic symptoms possibly entangled with other difficulties (learning, communication, attention ...). There is currently no gold standard in the literature for diagnosing APD. Investigators opened multidisciplinary consultation for the children suspected of APD. The purpose of this study is to analyze the results of the multidisciplinary assessment performed on these children (audiometry, cortical auditory brainstem response (ABR), behavioral assessment, psychometric evaluation, genetic analysis) to the results of functional MRI (fMRI) at rest and in activation. The goal is to find radiological MRI-fMRI markers in these patients that improve the diagnosis of APD.

Investigators will compare the f-MRI results between three groups of children in order to find specific radiological markers of APD :

  • group 1 : children diagnosed with an Auditory Processing Disorder (APD)
  • group 2 : children suspect of APD
  • group 3 : children without APD (controls)
Read the detailed description

The study will include a multidisciplinary consultation with:

  • Targeted behavioral assessment auditory processing disorder (APD): speech-in-noise perception, phonemic identification and discrimination, dichotic listening test, temporal processing tests, Random Gap Detection Threshold (RGDT) test.
  • Psychometric assessment: assessment of visual / auditory working memory, visual / auditory attention, study of cognitive functions.
  • Ear, Nose, Throat (ENT) examination with otoscopy, tonal and vocal audiometry and ABR recording.
  • Genetic analysis
  • Cortical auditory evoked potential (AEP) recording, compared with the automatized cortical AEP recording on Hear Lab machine.

The purpose of the study is looking for objective biomarkers of APD:

  • Compare EEG results with MRI-fMRI results
  • Analyze the cortical maturation of children who are fitted with hearings aids: second record of cortical APD performed one year after the fitting.
  • Compare the results after one year between group 1 ( with or without hearing aids) and children from group 2.
  • MRI-fMRI : to analyze the flow of perfusion, the DTI sequences, and the blood oxygen level-dependent (BOLD) effect (fMRI)

With this multidisciplinary evaluation, the investigators wish to improve the diagnosis of APD in suspected children by associating clinical, radiological, electro-physiological and genetic criteria.

Better understanding and more accurate diagnosis of APD's will improve the care management of these children.

Being tested
functional MRI, Automated Cortical Brainstem Auditory Evoked Potential, whole exome sequencing, Standard Cortical Brainstem Auditory Evoked Potential, multidisciplinary consultation
Keywords
auditory processing disorders, functional MRI
Medical subject headings
Auditory Perceptual Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • functional MRIDiagnostic test

    Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care

  • Automated Cortical Brainstem Auditory Evoked PotentialDiagnostic test

    Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG

  • whole exome sequencingGenetic

    A study of all the DNA-encoding exons of the child/parent from a sample taken as part of the usual care

  • Standard Cortical Brainstem Auditory Evoked PotentialDiagnostic test

    Standard Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG

  • multidisciplinary consultationDiagnostic test

    multidisciplinary consultation is composed of:

    • an ENT consultation and audiometry
    • a speech therapy assessment
    • a psychometric evaluation
Study groups in NCT03887182
Study groupRoleWhat they receive
confirmed auditory processing disordersExperimentalfunctional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
Receives: Diagnostic Test: functional MRI; Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential; Genetic: whole exome sequencing
suspected not confirmed auditory processing disordersExperimentalfunctional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
Receives: Diagnostic Test: functional MRI; Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential
healthy volunteersActive comparatorfunctional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation
Receives: Diagnostic Test: functional MRI; Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential; Diagnostic Test: Standard Cortical Brainstem Auditory Evoked Potential; Diagnostic Test: multidisciplinary consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BOLD effect

    BOLD effect is measured during fMRI and compared between the 3 groups of patients

    Measured: up to 4 weeks

Secondary outcomes (13)
  1. set disyllabic words (Fournier or Boorsma lists)

    Speech evaluation : set disyllabic words using the Fournier or Boorsma lists (the French equivalent of the. Peabody PBK test), depending on age

    Measured: up to 4 weeks

  2. RapDys

    Speech evaluation

    Measured: up to 4 weeks

  3. Random Gap Detection Test (RGDT)

    Speech evaluation

    Measured: up to 4 weeks

  4. Dichotic listening test

    Speech evaluation

    Measured: up to 4 weeks

  5. temporal pattern recognition test

    Speech evaluation

    Measured: up to 4 weeks

  6. Test of Everyday Attention for Children (TEA-Ch test)

    Psychometric evaluation for children aged 7-12 years

    Measured: up to 4 weeks

  7. Wechsler Intelligence Scale for Children (WISC-V) test

    Psychometric evaluation for children aged 13-18 years

    Measured: up to 4 weeks

  8. Chromosomal analysis (group 1 only)

    Genetic analysis

    Measured: up to 12 months

  9. Work Environment Scale (WES) sequencing (group 1 only)

    Genetic analysis

    Measured: up to 12 months

  10. Measures of P1, N1, P2, N2 waves' Latencies

    Cortical Brainstem Auditory Evoked

    Measured: At inclusion day (visit 1) and at 12 months (group 1 and 2 only)

  11. Measures of P1, N1, P2, N2 waves' amplitudes

    Cortical Brainstem Auditory Evoked

    Measured: At inclusion day (visit 1) and at 12 months (group 1 an 2 only)

  12. Infusion Rate (MRI-ASL)

    Infusion Rate (MRI-ASL) is measured during MRI

    Measured: up to 4 weeks

  13. tractography results (DTI sequence)

    tractography results (DTI sequence) is measured during MRI

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start2 Sep 2020
  3. Primary completion10 Oct 2023
  4. Study completion10 Oct 2023

Resources

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
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03887182
Sponsor's protocol ID
APHP180679
Other IDs
2018-A03239
Acronym
IRMf-TTA
Status last verified
Mar 2026
First submitted
12 Feb 2019
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chermak GD, Bamiou DE, Vivian Iliadou V, Musiek FE. Practical guidelines to minimise language and cognitive confounds in the diagnosis of CAPD: a brief tutorial. Int J Audiol. 2017 Jul;56(7):499-506. doi: 10.1080/14992027.2017.1284351. Epub 2017 Feb 28.

    PubMed 28635503
  • Moore DR, Ferguson MA, Edmondson-Jones AM, Ratib S, Riley A. Nature of auditory processing disorder in children. Pediatrics. 2010 Aug;126(2):e382-90. doi: 10.1542/peds.2009-2826. Epub 2010 Jul 26.

    PubMed 20660546
  • Barker MD, Kuruvilla-Mathew A, Purdy SC. Cortical Auditory-Evoked Potential and Behavioral Evidence for Differences in Auditory Processing between Good and Poor Readers. J Am Acad Audiol. 2017 Jun;28(6):534-545. doi: 10.3766/jaaa.16054.

    PubMed 28590897
  • Tomlin D, Rance G. Maturation of the Central Auditory Nervous System in Children with Auditory Processing Disorder. Semin Hear. 2016 Feb;37(1):74-83. doi: 10.1055/s-0035-1570328.

    PubMed 27587924
  • Sharma M, Purdy SC, Kelly AS. Comorbidity of auditory processing, language, and reading disorders. J Speech Lang Hear Res. 2009 Jun;52(3):706-22. doi: 10.1044/1092-4388(2008/07-0226). Epub 2008 Dec 8.

    PubMed 19064904
  • de Wit E, Visser-Bochane MI, Steenbergen B, van Dijk P, van der Schans CP, Luinge MR. Characteristics of Auditory Processing Disorders: A Systematic Review. J Speech Lang Hear Res. 2016 Apr 1;59(2):384-413. doi: 10.1044/2015_JSLHR-H-15-0118.

    PubMed 27082630
  • Demanez L, Dony-Closon B, Lhonneux-Ledoux E, Demanez JP. Central auditory processing assessment: a French-speaking battery. Acta Otorhinolaryngol Belg. 2003;57(4):275-90.

    PubMed 14714945
  • Sharma A, Kraus N, McGee TJ, Nicol TG. Developmental changes in P1 and N1 central auditory responses elicited by consonant-vowel syllables. Electroencephalogr Clin Neurophysiol. 1997 Nov;104(6):540-5. doi: 10.1016/s0168-5597(97)00050-6.

    PubMed 9402896
  • Sharma A, Dorman MF, Spahr AJ. Rapid development of cortical auditory evoked potentials after early cochlear implantation. Neuroreport. 2002 Jul 19;13(10):1365-8. doi: 10.1097/00001756-200207190-00030.

    PubMed 12151804
  • Sharma A, Martin K, Roland P, Bauer P, Sweeney MH, Gilley P, Dorman M. P1 latency as a biomarker for central auditory development in children with hearing impairment. J Am Acad Audiol. 2005 Sep;16(8):564-73. doi: 10.3766/jaaa.16.8.5.

    PubMed 16295243
  • Sharma A, Glick H, Campbell J, Biever A. CENTRAL AUDTIORY DEVELOPMENT IN CHILDREN WITH HEARING LOSS: CLINICAL RELEVANCE OF THE P1 CAEP BIOMARKER IN HEARING-IMPAIRED CHILDREN WITH MULTIPLE DISABILITIES. Hearing Balance Commun. 2013 Sep;11(3):10.3109/21695717.2013.812378. doi: 10.3109/21695717.2013.812378.

    PubMed 24273704
  • Sharma M, Purdy S C, Kelly A S. The contribution of speech-evoked cortical auditory evoked potentials to the diagnosis and measurement of intervention outcomes in children with auditory processing disorder. Semin Hear. 2014;35(1):51-64

  • Purdy SC, Kelly AS, Davies MG. Auditory brainstem response, middle latency response, and late cortical evoked potentials in children with learning disabilities. J Am Acad Audiol. 2002 Jul-Aug;13(7):367-82.

    PubMed 12199513
  • Anderson S, Chandrasekaran B, Yi HG, Kraus N. Cortical-evoked potentials reflect speech-in-noise perception in children. Eur J Neurosci. 2010 Oct;32(8):1407-13. doi: 10.1111/j.1460-9568.2010.07409.x.

    PubMed 20950282
  • Cunningham J, Nicol T, Zecker S, Kraus N. Speech-evoked neurophysiologic responses in children with learning problems: development and behavioral correlates of perception. Ear Hear. 2000 Dec;21(6):554-68. doi: 10.1097/00003446-200012000-00003.

    PubMed 11132782

Questions about this trial

What is this clinical trial studying?

A study testing functional MRI, Automated Cortical Brainstem Auditory Evoked Potential and whole exome sequencing in people with Auditory Processing Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BOLD effect (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887182, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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