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OpenTrials
Completed

NCT Number: NCT03971578

Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

The purpose of this study is to develop an Auditory Brainstem Response (ABR) based neurological screening method to detect increased risk for Autism Spectrum Disorders (ASD) and other neurological conditions in newborns.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

42 month–54 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami Department of Psychology

Coral Gables, Florida, 33124, United States

About this study

In the proposed study, a screening method for neurological deficits, with an emphasis on its application to ASD, will be developed and its feasibility demonstrated. The proposed method will utilize high rate stimulation to acquire Auditory Brainstem Responses in order to determine peak latency and amplitude differences in children with ASD compared to non-ASD. Similarly to newborn hearing screening, the output of the screening method will provide an automated pass or refer outcome that can be used by a physician to determine if the child needs further evaluation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with autism spectrum disorder diagnosis
  • Normally developing age- and gender-matched controls

Exclusion criteria

  • Permanent or temporary hearing loss at the time of testing.
  • Craniofacial abnormalities

Treatment and study plan

no intervention provided

Other

No Intervention Provided

Primary outcomes

  1. ABR Peak V Latency

    Time frame: One Week

    Auditory Brainstem Response (ABR) peak V latency measurement for the five stimulation rates used in the study. The latency is the time, measured in ms, from the onset of the stimulus to the generation of the response peak component. ABR peak V is the most prominent response peak component in humans.

Sponsors and collaborators

Lead sponsor

Intelligent Hearing Systems

Industry

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2019
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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