Autism Spectrum Disorder: BAEPs Findings and Behavioral Responses to Sounds

NCT05520632 | Recruiting DMC

• 1 other identifier: 2021.124(101.DEFI/104-CE)
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Findings in Brainstem Auditory Evoked Potentials (BAEP)

  Brainstem Auditory Evoked Potentials will be performed under propofol sedation. Absolute latencies (ALs) of waves I, III, and V and interpeak latencies (IPLs) I-III, III-V, and I-V were measured, as well as the amplitudes of waves I and V. These values will be compared between the group of cases (children with ASD) and controls (children without ASD). It will be evaluated whether any of these values will be persistently outside the values considered normal in children with ASD.

  3 years

Secondary Outcomes (2)

• Study of the sensory profile of children with autism spectrum disorder applying the "Child Sensory Profile 2" questionnaire

  3 years

• Study of the auditory profile of children with autism spectrum disorder applying the"Auditory Behavior Questionnaire" questionnaire

  3 years

Study Arms (2)

Children without autism spectrum disorder

Children without autism spectrum disorder undergoing BAEP

Diagnostic Test: Brainstem Auditory Evoked Potentials

Children with autism spectrum disorder

Children with autism spectrum disorder undergoing BAEP

Diagnostic Test: Brainstem Auditory Evoked Potentials

Interventions

Brainstem Auditory Evoked Potentials DIAGNOSTIC_TEST

Performing Brainstem Auditory Evoked Potentials under sedation

Children with autism spectrum disorder; Children without autism spectrum disorder

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All cases as children sent/followed up in the Development Consultation - Pediatrics, Pedopsychiatry or Pediatric Neurology diagnosed with ASD aged between 2 and 6 years (possible cases) and all children aged between 2 and 6 years who had scheduled PEATC in the ENT service in routine care (possible controls)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Ciências Biomédicas Abel Salazar: lead

Study Sites (1)

Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto (Abel Salazar Biomedical Sciences Institute - University of Porto)

Porto, 4050-313, Portugal

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Evoked Potentials, Auditory, Brain Stem

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Evoked Potentials, Auditory; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Vestibulocochlear Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joana Costa

  Instituto de Ciências Biomédicas Abel Salazar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joana Costa, MD

CONTACT

00351918109458; joana_cccosta@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

PT (1)