Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

/Autism Spectrum Disorder(ASD)Hearing Abnormalities Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03252392
Recruitment Status : Not yet recruiting
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
weaam noaman mohamed, Assiut University

Brief 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.

Condition or disease
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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Does Autism Spectrum Disorder(ASD)Show Any Degree of Hearing Abnormalities? :A Preliminary Study
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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 .

Layout table for additonal information
Responsible Party: weaam noaman mohamed, Principal invistigator, Assiut University
ClinicalTrials.gov Identifier: NCT03252392     History of Changes
Other Study ID Numbers: IRB17200055
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De identified IPD for all primary and secondary out come measures will be made available.
Time Frame: 6 months after publication
Access Criteria: Data access requests will be reviewed by an external independent review panel,Requesters will be required to sign a data access agreement

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by weaam noaman mohamed, Assiut University:
hearing and communication abnormalities

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Autistic Disorder
Congenital Abnormalities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders