Understanding sound responses in children with autism
Autism Spectrum Disorder: Brainstem Auditory Evoked Potential Findings and Behavioral Responses to Sounds
This study looks at how children with autism respond to sounds compared to kids without autism to see if understanding their brain responses can help improve their social skills and how they process sensory information.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 3 Years to 6 Years |
| Sex | All |
| Sponsor | Instituto de Ciências Biomédicas Abel Salazar Academic / other |
| Locations | 1 site (Porto) |
| Trial ID | NCT05520632 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the brainstem auditory evoked potentials (BAEP) findings in children diagnosed with Autism Spectrum Disorder (ASD) and compare them with typically developing peers. It focuses on analyzing specific auditory parameters and behavioral responses to sounds, utilizing tools like the Auditory Behavior Questionnaire and Child Sensory Profile 2. By establishing a relationship between BAEP findings and behavioral responses, the study seeks to inform targeted therapies that could improve social interactions and sensory processing in children with ASD.
Who should consider this trial
Good fit: Ideal candidates include children aged 3 to 6 years diagnosed with ASD according to DSM-V criteria and those with typical development requiring auditory assessments.
Not a fit: Patients over 6 years old or those with associated neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized therapies for children with autism, enhancing their ability to interact with their environment.
How similar studies have performed: While there are studies on sensory profiles in autism, this specific approach focusing on BAEP findings and behavioral responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Case group: children diagnosed with ASD according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorders 5th edition) and performed by a Pediatrician, Pedopsychiatry or Pediatric Neurologist; age between 3 and 6 years at the time of the audiological assessment; children with indication for BAEP; children who reveal thresholds within the normal range in the BAEP. * Control group: children with typical development for their age; children with indication for BAEP due to the presence of risk factors for deafness (included in the universal neonatal auditory screening program) or due to delay in language development alone requiring clarification; age between 3 and 6 years at the time of audiological examinations; children who reveal thresholds within the normal range in the BAEP. Exclusion Criteria: * Case group: late diagnosis of ASD (\> 6 years); associated pathology, such as: neurological (epilepsy, neurodegenerative disease, severe hypoxic-ischemic encephalopathy), congenital infections (TORCH group infections) with hearing impairment, chromosomal abnormalities (Down syndrome, fragile X syndrome), neurocutaneous syndromes, endocrine disorders and metabolic disorders (phenylketonuria), cleft palate or facial malformations; active ear pathology at the time of audiological evaluation (otitis media, external auditory canal infection or malformation); increase in auditory thresholds in BAEP. * Control group: associated pathology, such as: neurological (epilepsy, neurodegenerative disease, severe hypoxic-ischemic encephalopathy), congenital infections (TORCH group infections) with hearing loss, chromosomal abnormalities (Down syndrome, fragile X syndrome), neurocutaneous syndromes , endocrine and metabolic disorders (phenylketonuria), cleft palate or facial malformations; active ear pathology at the time of audiological evaluation (otitis media, external auditory canal infection or malformation); increase in auditory thresholds in BAEP.
Where this trial is running
Porto
- Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto (Abel Salazar Biomedical Sciences Institute - University of Porto) — Porto, Portugal (Recruiting)
Study contacts
- Principal investigator: Joana Costa — Instituto de Ciências Biomédicas Abel Salazar
- Study coordinator: Joana Costa, MD
- Email: joana_cccosta@hotmail.com
- Phone: 00351918109458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.