Autism Spectrum DisorderNCT03252392
/Autism Spectrum Disorder(ASD)Hearing Abnormalities Study
An observational study of Autism Spectrum Disorder, run by Assiut University.
Trial summary
Co morbidity rates of hearing loss in children with autism spectrum disorder are high and increasing. Investigators are aiming to: 1. evaluate peripheral auditory and brain stem auditory function in children with autism spectrum disorder. 2. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children aged 3-12 years old attending phoniatric unit of assiut university from october 2017 t0 october 2020.
Who may be able to join
- Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less)
Who cannot join
- children with otitis media with effusion.
- Associated neurological deficit .
About this study
Official title: Does Autism Spectrum Disorder(ASD)Show Any Degree of Hearing Abnormalities? :A Preliminary Study
Co morbidity rates of hearing loss in children with autism spectrum disorder are high and increasing.
Investigators are aiming to:
- evaluate peripheral auditory and brain stem auditory function in children with autism spectrum disorder.
- compare communication capabilities in autistic children having hearing abnormalities and autistic children with normal hearing.
Read the detailed description
Full audiological evaluation is carried out to all participants including:
- pure tone and speech audiometry.
- Tympanometry and acoustic reflex threshold evaluation.
- Threshold auditory brain stem response for threshold determination in non co operative children not respond to pure tone,speech audiometry.
- Auditory brain stem response for neuro-otologic diagnosis.
- Transient evoked otoacoustic emissions in children proved to have normal hearing to detect minimal cochlear affection .
- Transient evoked otoacoustic emissions with contralateral masking. Communication evaluation is carried out to all participants using arabic language test(kotby et al,1995).
Investigators use childhood autism rating scale for (CARS) for diagnosis of autism spectrum disorder.
- Conditions
- Autism Spectrum Disorder
- Keywords
- hearing and communication abnormalities
- 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.
| Study group | Role | What they receive |
|---|---|---|
| children with autism spectrum disorder | Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less) | |
| healthy non autistic age matched volunteers | children aged 3-12 years old never diagnosed to have autism spectrum disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of autistic participants suffering from hearing abnormalities.
Invistigators choose autistic children attending phoniatric unit in assiut university from october 2017 to october 2020 as they will go under complete audiological evaluation.
Measured: 3 years from october 2017 to october 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, weaam noaman mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252392
- Sponsor's protocol ID
- IRB17200055
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De identified IPD for all primary and secondary out come measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Autism Spectrum Disorder(ASD)Show Any Degree of Hearing Abnormalities? :A Preliminary Study
- ClinicalTrials.gov ID
- NCT03252392
- Acronym / sponsor ID
- IRB17200055
- Conditions
- Autism Spectrum Disorder
- Keywords
- hearing and communication abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Co morbidity rates of hearing loss in children with autism spectrum disorder are high and increasing.
Investigators are aiming to:
- evaluate peripheral auditory and brain stem auditory function in children with autism spectrum disorder.
- compare communication capabilities in autistic children having hearing abnormalities and autistic children with normal hearing.
Detailed description
Full audiological evaluation is carried out to all participants including:
- pure tone and speech audiometry.
- Tympanometry and acoustic reflex threshold evaluation.
- Threshold auditory brain stem response for threshold determination in non co operative children not respond to pure tone,speech audiometry.
- Auditory brain stem response for neuro-otologic diagnosis.
- Transient evoked otoacoustic emissions in children proved to have normal hearing to detect minimal cochlear affection .
- Transient evoked otoacoustic emissions with contralateral masking. Communication evaluation is carried out to all participants using arabic language test(kotby et al,1995).
Investigators use childhood autism rating scale for (CARS) for diagnosis of autism spectrum disorder.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with autism spectrum disorder | – | –Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less) |
| healthy non autistic age matched volunteers | – | –children aged 3-12 years old never diagnosed to have autism spectrum disorder |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children aged 3-12 years old attending phoniatric unit of assiut university from october 2017 t0 october 2020.
Key inclusion criteria (1 listed)
- Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less)
Key exclusion criteria (2 listed)
- children with otitis media with effusion.
- Associated neurological deficit .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of autistic participants suffering from hearing abnormalities.
Time frame: 3 years from october 2017 to october 2020
Invistigators choose autistic children attending phoniatric unit in assiut university from october 2017 to october 2020 as they will go under complete audiological evaluation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Individual participant dataSharing planned: Yes. De identified IPD for all primary and secondary out come measures will be made available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Number of autistic participants suffering from hearing abnormalities. (time frame: 3 years from october 2017 to october 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2017; AzTrials last refreshed its copy on 2 Nov 2026.