Autism Spectrum DisorderNCT03971578
Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
An observational study of Autism Spectrum Disorder, run by Intelligent Hearing Systems at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 31 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with autism spectrum disorders and normally developing age- and gender-matched controls
Who may be able to join
- Children with autism spectrum disorder diagnosis
- Normally developing age- and gender-matched controls
Who cannot join
- Permanent or temporary hearing loss at the time of testing.
- Craniofacial abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Department of Psychology
Coral Gables, Florida, 33124
About this study
Official title: Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- No Intervention Provided
- Keywords
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention ProvidedOther
No Intervention Provided
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorders Group | Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old Receives: 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 Receives: Other: No Intervention Provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Feb 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intelligent Hearing Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971578
- Sponsor's protocol ID
- ASDCLAD001
- Status last verified
- Aug 2023
- First submitted
- 30 May 2019
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summary data will be disseminated
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.
PubMed 29087045
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution
- ClinicalTrials.gov ID
- NCT03971578
- Acronym / sponsor ID
- ASDCLAD001
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Intelligent Hearing SystemsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorders Group | – | Other: No Intervention ProvidedChildren identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old |
| Normal Control Group | – | Other: No Intervention ProvidedNormal children without Autism Spectrum Disorder or other identified developmental disability Age: 3.5 to 4.5 years old |
Who may qualify
- Ages
- 42 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with autism spectrum disorders and normally developing age- and gender-matched controls
Key inclusion criteria (2 listed)
- Children with autism spectrum disorder diagnosis
- Normally developing age- and gender-matched controls
Key exclusion criteria (2 listed)
- Permanent or temporary hearing loss at the time of testing.
- Craniofacial abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention ProvidedNo Intervention Provided | Other | Autism Spectrum Disorders Group, Normal Control Group |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29087045Miron 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.
- Individual participant dataSharing planned: No. Summary data will be disseminated
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Intelligent Hearing Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABR Peak V Latency (time frame: One Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03971578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.