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.
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.
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.
- Conditions
- Auditory Processing Disorders
- 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 group | Role | What they receive |
|---|---|---|
| confirmed auditory processing disorders | Experimental | functional 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 disorders | Experimental | functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic Receives: Diagnostic Test: functional MRI; Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential |
| healthy volunteers | Active comparator | functional 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.
BOLD effect
BOLD effect is measured during fMRI and compared between the 3 groups of patients
Measured: up to 4 weeks
Secondary outcomes (13)
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
RapDys
Speech evaluation
Measured: up to 4 weeks
Random Gap Detection Test (RGDT)
Speech evaluation
Measured: up to 4 weeks
Dichotic listening test
Speech evaluation
Measured: up to 4 weeks
temporal pattern recognition test
Speech evaluation
Measured: up to 4 weeks
Test of Everyday Attention for Children (TEA-Ch test)
Psychometric evaluation for children aged 7-12 years
Measured: up to 4 weeks
Wechsler Intelligence Scale for Children (WISC-V) test
Psychometric evaluation for children aged 13-18 years
Measured: up to 4 weeks
Chromosomal analysis (group 1 only)
Genetic analysis
Measured: up to 12 months
Work Environment Scale (WES) sequencing (group 1 only)
Genetic analysis
Measured: up to 12 months
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)
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)
Infusion Rate (MRI-ASL)
Infusion Rate (MRI-ASL) is measured during MRI
Measured: up to 4 weeks
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.
- First posted22 Mar 2019
- Study start2 Sep 2020
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Auditory Processing DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Isabelle Rouillon, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
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 28635503Moore 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 20660546Barker 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 28590897Tomlin 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 27587924Sharma 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 19064904de 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 27082630Demanez 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 14714945Sharma 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 9402896Sharma 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 12151804Sharma 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 16295243Sharma 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 24273704Sharma 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 12199513Anderson 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 20950282Cunningham 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Functional MRI in Assessment of Auditory Processing Disorders
- ClinicalTrials.gov ID
- NCT03887182
- Acronym / sponsor ID
- IRMf-TTA / APHP180679
- Conditions
- Auditory Processing Disorders
- Keywords
- auditory processing disorders, functional MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| confirmed auditory processing disorders | Experimental | Diagnostic Test: functional MRI, Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential, Genetic: whole exome sequencingfunctional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic |
| suspected not confirmed auditory processing disorders | Experimental | Diagnostic Test: functional MRI, Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potentialfunctional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic |
| healthy volunteers | Active comparator | Diagnostic Test: functional MRI, Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential, Diagnostic Test: Standard Cortical Brainstem Auditory Evoked Potential, Diagnostic Test: multidisciplinary consultationfunctional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional MRIAdditional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care | Diagnostic test | confirmed auditory processing disorders, healthy volunteers, suspected not confirmed auditory processing disorders |
| Automated Cortical Brainstem Auditory Evoked PotentialAutomated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG | Diagnostic test | confirmed auditory processing disorders, healthy volunteers, suspected not confirmed auditory processing disorders |
| whole exome sequencingA study of all the DNA-encoding exons of the child/parent from a sample taken as part of the usual care | Genetic | confirmed auditory processing disorders |
| Standard Cortical Brainstem Auditory Evoked PotentialStandard Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG | Diagnostic test | healthy volunteers |
| multidisciplinary consultationmultidisciplinary consultation is composed of: * an ENT consultation and audiometry * a speech therapy assessment * a psychometric evaluation | Diagnostic test | healthy volunteers |
Primary outcome
BOLD effect
Time frame: up to 4 weeks
BOLD effect is measured during fMRI and compared between the 3 groups of patients
13 secondary outcomes
set disyllabic words (Fournier or Boorsma lists)
Time frame: up to 4 weeks
RapDys
Time frame: up to 4 weeks
Random Gap Detection Test (RGDT)
Time frame: up to 4 weeks
Dichotic listening test
Time frame: up to 4 weeks
temporal pattern recognition test
Time frame: up to 4 weeks
Test of Everyday Attention for Children (TEA-Ch test)
Time frame: up to 4 weeks
Wechsler Intelligence Scale for Children (WISC-V) test
Time frame: up to 4 weeks
Chromosomal analysis (group 1 only)
Time frame: up to 12 months
Work Environment Scale (WES) sequencing (group 1 only)
Time frame: up to 12 months
Measures of P1, N1, P2, N2 waves' Latencies
Time frame: At inclusion day (visit 1) and at 12 months (group 1 and 2 only)
Measures of P1, N1, P2, N2 waves' amplitudes
Time frame: At inclusion day (visit 1) and at 12 months (group 1 an 2 only)
Infusion Rate (MRI-ASL)
Time frame: up to 4 weeks
tractography results (DTI sequence)
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 28635503Chermak 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.
- Background: PubMed 20660546Moore 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.
- Background: PubMed 28590897Barker 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.
- Background: PubMed 27587924Tomlin 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.
- Background: PubMed 19064904Sharma 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.
- Background: PubMed 27082630de 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.
- Background: PubMed 14714945Demanez 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.
- Background: PubMed 9402896Sharma 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.
- Background: PubMed 12151804Sharma 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.
- Background: PubMed 16295243Sharma 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.
- Background: PubMed 24273704Sharma 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.
- BackgroundSharma 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Rouillon, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.