Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971578
• Other study ID #: ASDCLAD001
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2023
• Source: Intelligent Hearing Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Months to 54 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• No Intervention Provided
No Intervention Provided

Locations

Country	Name	City	State
United States	University of Miami Department of Psychology	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Intelligent Hearing Systems	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miron O, Beam AL, Kohane IS. Auditory brainstem response in infants and children with autism spectrum disorder: A meta-analysis of wave V. Autism Res. 2018 Feb;11(2):355-363. doi: 10.1002/aur.1886. Epub 2017 Oct 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABR Peak V Latency	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.	One Week