Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

Intelligent Hearing Systems

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Other: No Intervention Provided

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT03971578

ASDCLAD001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 42 to 54 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

81 participants in 2 patient groups

Autism Spectrum Disorders Group

Description:

Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old

Treatment:

Other: No Intervention Provided

Normal Control Group

Description:

Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 3.5 to 4.5 years old

Treatment:

Other: No Intervention Provided