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Clinical Trials/NCT03971578
NCT03971578
Completed
N/A

Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution

Intelligent Hearing Systems1 site in 1 country81 target enrollmentFebruary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Intelligent Hearing Systems
Enrollment
81
Locations
1
Primary Endpoint
ABR Peak V Latency
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
July 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Intelligent Hearing Systems
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

ABR Peak V Latency

Time Frame: 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.

Study Sites (1)

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