/Autism Spectrum Disorder(ASD)Hearing Abnormalities Study

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:

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder

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 Type: Observational
• Enrollment (Anticipated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children aged 3-12 years old attending phoniatric unit of assiut university from october 2017 t0 october 2020.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: hearing and communication abnormalities
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Congenital Abnormalities; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: IRB17200055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De identified IPD for all primary and secondary out come measures will be made available.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel,Requesters will be required to sign a data access agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No