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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03252392
Other study ID # IRB17200055
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 14, 2017
Last updated August 15, 2017
Start date October 1, 2017
Est. completion date October 1, 2020

Study information

Verified date August 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. compare communication capabilities in autistic children having hearing abnormalities and autistic children with normal hearing.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria:

- Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less)

Exclusion Criteria:

- children with otitis media with effusion.

- Associated neurological deficit .

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 years from october 2017 to october 2020
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