NCT05520632 Autism Spectrum Disorder: BAEPs Findings and Behavioral Responses to Sounds
| NCT ID | NCT05520632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Ciências Biomédicas Abel Salazar |
| Condition | Autism Spectrum Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2023-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2022-05-01 with a primary completion date of 2023-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There are many studies in the literature that study the sensory profile of children with autism spectrum disorder (ASD), which can essentially have three types of behavior: (1) Registration, (2) Seeking, (3) Sensitivity, and (4) Avoiding. However, there are few studies dedicated to the study of the sensory profile of children with autism. A child's sensory profile is closely related to the way they deal with the world and their social interaction. The existence of tools that allow the study of the behavioral response to the sounds of children with autism spectrum disorder, will allow the application of targeted therapies in the future. Therapies targeted and adjusted to each profile observed in these children will allow to attenuate these maladjusted behavioral responses, or even overcome these deficits, if there is an early and precise intervention.
Eligibility 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.
Contact & Investigator
Joana Costa
PRINCIPAL INVESTIGATOR
Instituto de Ciências Biomédicas Abel Salazar
Frequently Asked Questions
Who can join the NCT05520632 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 6 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05520632 currently recruiting?
Yes, NCT05520632 is actively recruiting participants. Contact the research team at joana_cccosta@hotmail.com for enrollment information.
Where is the NCT05520632 trial being conducted?
This trial is being conducted at Porto, Portugal.
Who is sponsoring the NCT05520632 clinical trial?
NCT05520632 is sponsored by Instituto de Ciências Biomédicas Abel Salazar. The principal investigator is Joana Costa at Instituto de Ciências Biomédicas Abel Salazar. The trial plans to enroll 120 participants.