Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution
1 other identifier
observational
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedResults Posted
Study results publicly available
August 14, 2023
CompletedAugust 14, 2023
August 1, 2023
2.5 years
May 30, 2019
July 14, 2023
August 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ABR Peak V Latency
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.
One Week
Study Arms (2)
Autism Spectrum Disorders Group
Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old
Normal Control Group
Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 3.5 to 4.5 years old
Interventions
No Intervention Provided
Eligibility Criteria
Children with autism spectrum disorders and normally developing age- and gender-matched controls
You may qualify if:
- Children with autism spectrum disorder diagnosis
- Normally developing age- and gender-matched controls
You may not qualify if:
- Permanent or temporary hearing loss at the time of testing.
- Craniofacial abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Department of Psychology
Coral Gables, Florida, 33124, United States
Related Publications (1)
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.
PMID: 29087045BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Rafael E. Delgado, Director of Research & Development
- Organization
- Intelligent Hearing Systems
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2019
First Posted
June 3, 2019
Study Start
February 1, 2020
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
August 14, 2023
Results First Posted
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
Summary data will be disseminated