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Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03971578
Recruitment Status : Completed
First Posted : June 3, 2019
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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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 : February 1, 2020
Actual Primary Completion Date : July 31, 2022
Actual Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. ABR Peak Latency and Amplitude [ Time Frame: One Week ]
    ABR Peak Latency and Amplitude



Information from the National Library of Medicine

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Ages Eligible for Study:   42 Months to 54 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with autism spectrum disorders and normally developing age- and gender-matched controls
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971578


Locations
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United States, Florida
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)
Publications:
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Responsible Party: Intelligent Hearing Systems
ClinicalTrials.gov Identifier: NCT03971578    
Other Study ID Numbers: ASDCLAD001
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Summary data will be disseminated

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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:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders