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Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

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ClinicalTrials.gov Identifier: NCT03971578
Recruitment Status : Not yet recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Intelligent Hearing Systems

Tracking Information
First Submitted Date May 30, 2019
First Posted Date June 3, 2019
Last Update Posted Date June 3, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2019)
ABR Peak Latency and Amplitude [ Time Frame: One Week ]
ABR Peak Latency and Amplitude
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Official Title Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with autism spectrum disorders and normally developing age- and gender-matched controls
Condition Autism Spectrum Disorder
Intervention Other: No Intervention Provided
No Intervention Provided
Study Groups/Cohorts
  • Autism Spectrum Disorders Group
    Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old
    Intervention: 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
    Intervention: Other: No Intervention Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 31, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 42 Months to 54 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Christine Delgado, PhD 305-284-2814 cdelgado@umiami.edu
Contact: Rafael Delgado, PhD 305-668-6102 redelgado@ihsys.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03971578
Other Study ID Numbers ASDCLAD001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Summary data will be disseminated
Responsible Party Intelligent Hearing Systems
Study Sponsor Intelligent Hearing Systems
Collaborators National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators Not Provided
PRS Account Intelligent Hearing Systems
Verification Date May 2019