Assessment of Children by Speech ABR

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06061458
Collaborator
(none)
100
4
26

Study Details

Study Description

Brief Summary

Assessment of children by speech auditory brainstem response which is an objective method to study the speech development

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: speech auditory brainstem response
N/A

Detailed Description

Hearing loss in children can result in cognitive deficits in the central areas which are dependent upon hearing, therefore responsible for delay in speech development, poor language skills and disorders in psychological and mental behavior. It will also cause a decrease of the intellectual ability and socio-economic position of the child.

In children aged 3.5 years and older, pure tone audiometry is performed to determine the exact frequency-specific hearing threshold.

To obtain the auditory threshold in younger children, Skoe and Kraus reported that the auditory brainstem response has proven to be a clinically useful tool for assessing neural function at the brainstem level and is most commonly elicited by clicks or tone-bursts.

However, recent research has established that complex stimuli can also elicit the response such as Music, complex tones, and speech stimuli . A speech stimulus is particularly useful, as it can provide clues as to how temporal and spectral features are preserved in the brainstem.

The human soundscape is characterized by complex sounds with rich harmonic structure, dynamic amplitude modulations and rapid spectro-temporal fluctuations. This complexity is represented by temporal and spectral neural code within the auditory brainstem, two broad classes of time-locked responses can be defined namely transient and sustained responses .

Although complex sounds consist of both sustained and transient features, the response to a complex sound is not necessarily predictable from the response to click auditory brainstem response . For these reason, further studies had gradually transitioned to using sounds as stimuli as they are more complex .

The click auditory brainstem response is a clinical tool to assess the neural functionality of the auditory brainstem. The use of verbal stimuli in auditory brainstem response protocols has provided important information of how the speech stimuli are processed by the brainstem structure .

The perception of speech sounds seems to begin in the brainstem, which has an important role in the reading process and the phonological acquisition . Speech auditory brainstem response assessment allows the identification of fine-grained auditory processing deficits associated with real world communication which do not appear in click evoked auditory brainstem response .

The verbal stimulus most widely used in speech auditory brainstem response is a syllable composed of a consonant and a vowel , usually the syllables da. The verbal assessment provides information about how the speech syllable is encoded by auditory system. The trace of the speech auditory brainstem response can be identified in two parts:

The onset and the frequency following response . The first part represents the consonant and the second part represents the vowel .

So speech auditory brainstem response can be used as an objective measure of the hearing function, one of the great advantages of this method is that it is not influenced by environmental issues, which can disrupt the behavioral assessments . Even the best behavioral tests can be affected by multiple factors such as attention, motivation and alertness or fatigue .

Moreover, altered responses of speech auditory brainstem response may be associated with impaired speech perception specially in noise. These changes can cause a negative impact on communication and serious consequences for academic success in children. complex auditory brainstem response can also help to identify those individuals who are most likely to benefit from auditory training .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Children With Variable Hearing Amplification Devices by Speech Auditory Brainstem Response
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

normal hearing

Experimental: the group with hearing aids

children with hearing aids

Diagnostic Test: speech auditory brainstem response
A diagnostic objective test to evaluate the speech process in hearing impaired children

Experimental: the group with cochlear implant

children with cochlear implant

Diagnostic Test: speech auditory brainstem response
A diagnostic objective test to evaluate the speech process in hearing impaired children

Experimental: the group with bimodal hearing

children with bimodal hearing

Diagnostic Test: speech auditory brainstem response
A diagnostic objective test to evaluate the speech process in hearing impaired children

Outcome Measures

Primary Outcome Measures

  1. speech process in the groups [30 minutes after the test]

    presence of the waves in the test traces

Secondary Outcome Measures

  1. best hearing amplification device [30 minutes after the test]

    best waves of the test traces

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Control group: (25) Children with normal peripheral hearing bilaterally their age is matched with the study group.

  • Study group: three study groups, each study group has (25) children using, binaural

Hearing aids, Cochlear implant and bimodal hearing with:
  • Average IQ.

  • No other congenital diseases affecting the speech progress.

  • Using the hearing device for at least one year.

  • Regular speech therapy sessions

Exclusion Criteria:

• Any other children not fulfilling the inclusion criteria or refuse to participate in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
kholoud omar, MD, Principle Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06061458
Other Study ID Numbers:
  • ACDS
First Posted:
Sep 29, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2023