Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

NCT ID: NCT03971578

Last Updated: 2023-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Autism Spectrum Disorders Group

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

No Intervention Provided

Intervention Type OTHER

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

No Intervention Provided

Intervention Type OTHER

No Intervention Provided

Interventions

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No Intervention Provided

No Intervention Provided

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

42 Months

Maximum Eligible Age

54 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Intelligent Hearing Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Miami Department of Psychology

Coral Gables, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29087045 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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ASDCLAD001

Identifier Type: -

Identifier Source: org_study_id

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