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Clinical Trials/NCT06061458
NCT06061458UnknownNot Applicable

Assessment of Children With Variable Hearing Amplification Devices by Speech Auditory Brainstem Response

Assiut University0 sites100 target enrollmentStarted: October 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Primary Endpoint
speech process in the groups

Study Overview

Brief Summary

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

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 .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
5 Years to 12 Years (Child)
Sex
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.

Arms & Interventions

control group

No Intervention

normal hearing

the group with hearing aids

Experimental

children with hearing aids

Intervention: speech auditory brainstem response (Diagnostic Test)

the group with cochlear implant

Experimental

children with cochlear implant

Intervention: speech auditory brainstem response (Diagnostic Test)

the group with bimodal hearing

Experimental

children with bimodal hearing

Intervention: speech auditory brainstem response (Diagnostic Test)

Outcomes

Primary Outcomes

speech process in the groups

Time Frame: 30 minutes after the test

presence of the waves in the test traces

Secondary Outcomes

  • best hearing amplification device(30 minutes after the test)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

kholoud omar, MD

Principle Investigator

Assiut University

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