NCT03252392

Brief Summary

Co morbidity rates of hearing loss in children with autism spectrum disorder are high and increasing. Investigators are aiming to:

  1. 1.evaluate peripheral auditory and brain stem auditory function in children with autism spectrum disorder.
  2. 2.compare communication capabilities in autistic children having hearing abnormalities and autistic children with normal hearing.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

August 14, 2017

Last Update Submit

August 15, 2017

Conditions

Keywords

hearing and communication abnormalities

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • children with otitis media with effusion.
  • Associated neurological deficit .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal invistigator

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 17, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

August 17, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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