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Autism Spectrum DisorderNCT07743177

Auditory Brainstem Evoked Potentials in Autism Spectrum Disorder

An observational study of Autism Spectrum Disorder, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This retrospective study investigates auditory brainstem evoked potentials (BAEPs) in children with autism spectrum disorder (ASD) compared with other neuropsychiatric conditions. The study aims to evaluate differences in BAEP parameters, with particular attention to sex- and age-related effects and clinical severity Read more about this study

Who is it for?
Ages 2 to 5 years
Conditions the study is for
Autism Spectrum Disorder
How many people
200 participants
Where
1 siteItaly
Study dates
31 Mar 2026to 31 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 5 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children between 2 and 5 years with autism spectrum disorder

Who may be able to join

  • Children aged 2-5 years
  • BAEP examination performed at IRCCS Fondazione Mondino between January 2021 and December 2023
  • Diagnosis/Suspicion of autism spectrum disorder or other neuropsychiatric conditions
  • Availability of technically reliable BAEP recordings

Who cannot join

  • Non-interpretable BAEP recordings due to lack of cooperation

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Translational Neurophysiology

    Pavia, 27100

Other trials in Italy

About this study

Official title: Auditory Brainstem Evoked Potentials in Autism Spectrum Disorder: A Window on Neural Maturation and Sex Differences

This retrospective study investigates auditory brainstem evoked potentials (BAEPs) in children with autism spectrum disorder (ASD) compared with other neuropsychiatric conditions. The study aims to evaluate differences in BAEP parameters, with particular attention to sex- and age-related effects and clinical severity

Read the detailed description

Autism spectrum disorder is a neurodevelopmental condition frequently associated with atypical sensory processing, particularly in the auditory domain. BAEPs provide an objective neurophysiological measure of auditory pathway integrity and maturation at the brainstem level.

This study retrospectively analyzes BAEP recordings collected at IRCCS Fondazione Mondino between January 2021 and December 2023. Latencies of waves I, III, and V, as well as interpeak intervals (I-III, III-V, I-V), are compared between children with ASD and children with other neuropsychiatric conditions.

Secondary analyses explore associations between BAEP parameters, ASD severity, age, and sex, in order to clarify potential neurobiological differences and evaluate BAEPs as candidate electrophysiological biomarkers for ASD.

Keywords
Autism Spectrum Disorder, Auditory Brainstem Evoked Potentials, Auditory Processing, Neurodevelopment
Medical subject headings
Autism Spectrum Disorder

What is being measured

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

  1. Differences in BAEP interpeak intervals (I-III, III-V, I-V)

    Differences in BAEP interpeak intervals (I-III, III-V, I-V) between children with ASD and other neuropsychiatric conditions

    Measured: Single assessment at admission between 2021 and 2023 (retrospective analysis)

  2. Differences in BAEP wave latencies (I, III, V)

    Differences in BAEP wave latencies (I, III, V) and interpeak intervals (I-III, III-V, I-V) between children with ASD and other neuropsychiatric conditions

    Measured: Single assessment at admission between 2021 and 2023 (retrospective analysis)

Secondary outcomes (3)

  1. BAEP parameters and ASD severity

    Correlation between BAEP parameters and ASD severity

    Measured: Single assessment at admission between 2021 and 2023 (retrospective analysis)

  2. BAEP parameters and age

    Correlation between BAEP parameters and age

    Measured: Single assessment at admission between 2021 and 2023 (retrospective analysis)

  3. BAEP parameters and sex

    Correlation between BAEP parameters and sex

    Measured: Single assessment at admission between 2021 and 2023 (retrospective analysis)

Timeline

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

  1. First posted3 Aug 2026
  2. Study start31 Mar 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07743177
Sponsor's protocol ID
BAEP
Status last verified
Jul 2026
First submitted
29 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bomba, M. D., & Pang, E. W. (2021). Auditory brainstem response in autism spectrum disorder: Sex differences and implications for neural connectivity. Journal of Autism and Developmental Disorders, 51(4), 1201-1215. https://doi.org/10.1007/s10803-020-04605-2

  • Gonçalves, S. I., Schafer, R. J., Garreau, C. R., & Smith, M. E. (2019). Auditory processing in autism spectrum disorder: A review of electrophysiological and neuroimaging findings. Neuropsychology Review, 29(2), 150-163. https://doi.org/10.1007/s11065-019-09399-8

  • Davies, P. L., & Gavin, W. J. (2018). Examining auditory processing in children with autism spectrum disorder: A meta- analytic review of event-related potential studies. Journal of Autism and Developmental Disorders, 48(6), 2037-2051. https://doi.org/10.1007/s10803-018-3464-3

  • Jeste SS, Nelson CA 3rd. Event related potentials in the understanding of autism spectrum disorders: an analytical review. J Autism Dev Disord. 2009 Mar;39(3):495-510. doi: 10.1007/s10803-008-0652-9. Epub 2008 Oct 11.

    PubMed 18850262

  • Marco EJ, Hinkley LB, Hill SS, Nagarajan SS. Sensory processing in autism: a review of neurophysiologic findings. Pediatr Res. 2011 May;69(5 Pt 2):48R-54R. doi: 10.1203/PDR.0b013e3182130c54.

    PubMed 21289533

  • Miron, O., Beam, A. L., Kohane, I. S., & Nelson, C. A. (2015). Auditory brainstem response abnormalities in autism spectrum disorder: A meta-analysis. Pediatrics, 136(4), e967-e977. https://doi.org/10.1542/peds.2015-1082

  • Miron, O., Foxe, J. J., VanMeter, J. W., & Molholm, S. (2016). Atypical auditory processing in autism spectrum disorder: A review of neurophysiological and neuroimaging studies. Neuroscience & Biobehavioral Reviews, 71, 701-714. https://doi.org/10.1016/j.neubiorev.2016.10.009

  • Roberts, T. P., Cannon, K. M., Tavabi, K., Blaskey, L., Khan, S. Y., Monroe, J. F., ... & Edgar, J. C. (2019). Auditory processing deficits in children with autism spectrum disorder assessed using magnetoencephalography. NeuroImage: Clinical, 21, 101664. https://doi.org/10.1016/j.nicl.2019.101664

  • Roberts, T. P., Schmidt, G. L., Egeth, M., Blaskey, L., Rey, M. M., Khan, S. Y., & Edgar, J. C. (2011). Electrophysiological signatures of atypical auditory processing in autism spectrum disorder. Autism Research, 4(5), 318-331. https://doi.org/10.1002/aur.201

  • Smith, E. G., & Bennetto, L. (2021). The effects of sex differences on auditory processing in autism spectrum disorder: Implications for language development. Journal of Speech, Language, and Hearing Research, 64(3), 890-905. https://doi.org/10.1044/2021_JSLHR-20-00498

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

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?

Differences in BAEP interpeak intervals (I-III, III-V, I-V) (time frame: Single assessment at admission between 2021 and 2023 (retrospective analysis)). The study lists 2 primary outcomes in all. 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 NCT07743177, which also lists 10 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 3 Aug 2026.

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