Auditory Steady State Response vsAuditory Brainstem Response

July 30, 2019 updated by: Ahmed Galal Ibrahem, Assiut University

[ASSR] in Hearing Impaired Children With Absent [ABR] Waves

All children with hearing loss should have access to resources necessary to reach their maximum potential. The following principles provide the foundation for effective EHDI[Early Hearing Detection & Intervention] systems and have been updated and expanded since the 2000 JCIH [ joint Committee on Infant Hearing ] position statement .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. All infants should have access to hearing screening using a physiologic measure at no later than 1 month of age.
  2. All infants who do not pass the initial hearing screening and the subsequent rescreening should have appropriate audiological and medical evaluations to confirm the presence of hearing loss at no later than 3 months of age.
  3. All infants with confirmed permanent hearing loss should receive early intervention services as soon as possible after diagnosis but at no later than 6 months of age. A simplified, single point of entry into an intervention system that is appropriate for children with hearing loss is optimal.

The importance of early identification and habilitation of hearing loss for improved access to auditory stimuli and for positive prognosis of speech and language is well established in the literature . Auditory brain stem response (ABR) is the most commonlly used test in clinical practice to estimate the degree of hearing loss, but the auditory brainstem response (ABR) cannot differentiate between severe and profound SNHL [5], whereas the ASSR can provide threshold information in a frequency-specific manner at intensity levels of 120 dB and higher. This intensity stimulation advantage uniquely qualifies the ASSR for investigation of residual hearing in young and difficult-to-test cochlear implant candidates.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Evaluate of residual hearing function in hearing impaired children with absent ABR waves and normal middle ear pressure.

Description

Inclusion Criteria:

  • Absent ABR [Auditory Breanstem Response] waves .
  • normal middle ear function

Exclusion Criteria:

  • Ears with otitis media with effusion,
  • Preserved otoacuastic emission ,
  • Preserved ABR waves .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A 40 hearing impaired children with absent ABR waves
Time Frame: one year
evaluation by auditory steady state response (ASSR)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
After ASSR evaluation for this patient we can take decision either for hearing aid amplification of for (surgery) cochlear implant .
Time Frame: one year
evaluation by auditory steady state response (ASSR)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100772

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Impaired Children

Clinical Trials on Evoked potential audiometer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe