Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Other: No Intervention Provided

• Registration Number: NCT03971578
• Lead Sponsor: Intelligent Hearing Systems

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2020-02-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Results First Submitted: 2023-07-14
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-08
• Last Update Submitted: 2023-08-08
• Results First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autism Spectrum Disorders Group	No Intervention Provided	Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old
Normal Control Group	No Intervention Provided	Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 3.5 to 4.5 years old

Primary Outcome Measures

Name	Time	Method
ABR Peak V Latency	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.

Trial Locations

Locations (1)

University of Miami Department of Psychology; 🇺🇸 Coral Gables, Florida, United States