Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

• Sponsor: Intelligent Hearing Systems (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03971578
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 75
• Location: 1
• Actual Duration (Months): 29.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Other: No Intervention Provided

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 Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Jul 31, 2022
• Actual Study Completion Date: Jul 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ABR Peak Latency and Amplitude [One Week]

   ABR Peak Latency and Amplitude

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Months to 54 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Department of Psychology	Coral Gables	Florida	United States	33124

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Intelligent Hearing Systems
• ClinicalTrials.gov Identifier: NCT03971578
• Other Study ID Numbers: ASDCLAD001
• First Posted: Jun 3, 2019
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Intelligent Hearing Systems: Autism Spectrum Disorder
• Additional relevant MeSH terms: Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Aug 3, 2022