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Assessment of Children by Speech ABR

Primary Purpose

Hearing Impaired Children

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
speech auditory brainstem response
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hearing Impaired Children

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    control group

    the group with hearing aids

    the group with cochlear implant

    the group with bimodal hearing

    Arm Description

    normal hearing

    children with hearing aids

    children with cochlear implant

    children with bimodal hearing

    Outcomes

    Primary Outcome Measures

    speech process in the groups
    presence of the waves in the test traces

    Secondary Outcome Measures

    best hearing amplification device
    best waves of the test traces

    Full Information

    First Posted
    September 14, 2023
    Last Updated
    September 30, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06061458
    Brief Title
    Assessment of Children by Speech ABR
    Official Title
    Assessment of Children With Variable Hearing Amplification Devices by Speech Auditory Brainstem Response
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 . 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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Impaired Children

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    normal hearing
    Arm Title
    the group with hearing aids
    Arm Type
    Experimental
    Arm Description
    children with hearing aids
    Arm Title
    the group with cochlear implant
    Arm Type
    Experimental
    Arm Description
    children with cochlear implant
    Arm Title
    the group with bimodal hearing
    Arm Type
    Experimental
    Arm Description
    children with bimodal hearing
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    speech auditory brainstem response
    Intervention Description
    A diagnostic objective test to evaluate the speech process in hearing impaired children
    Primary Outcome Measure Information:
    Title
    speech process in the groups
    Description
    presence of the waves in the test traces
    Time Frame
    30 minutes after the test
    Secondary Outcome Measure Information:
    Title
    best hearing amplification device
    Description
    best waves of the test traces
    Time Frame
    30 minutes after the test

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amal Mohamed, professor
    Phone
    01003676677
    Email
    amalelattar99@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Enas Moustafa, lecturer
    Phone
    01061121765
    Email
    Enasosman101@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The protocol
    Citations:
    PubMed Identifier
    36651959
    Citation
    Basoz Behmen M, Guler N, Kuru E, Bal N, Gedik Toker O. Speech auditory brainstem response in audiological practice: a systematic review. Eur Arch Otorhinolaryngol. 2023 May;280(5):2099-2118. doi: 10.1007/s00405-023-07830-3. Epub 2023 Jan 18.
    Results Reference
    result
    PubMed Identifier
    20121865
    Citation
    Basu M, Krishnan A, Weber-Fox C. Brainstem correlates of temporal auditory processing in children with specific language impairment. Dev Sci. 2010 Jan 1;13(1):77-91. doi: 10.1111/j.1467-7687.2009.00849.x.
    Results Reference
    result
    PubMed Identifier
    10862922
    Citation
    Walch C, Anderhuber W, Kole W, Berghold A. Bilateral sensorineural hearing disorders in children: etiology of deafness and evaluation of hearing tests. Int J Pediatr Otorhinolaryngol. 2000 Jun 9;53(1):31-8. doi: 10.1016/s0165-5876(00)00307-4.
    Results Reference
    result
    PubMed Identifier
    20084007
    Citation
    Skoe E, Kraus N. Auditory brain stem response to complex sounds: a tutorial. Ear Hear. 2010 Jun;31(3):302-24. doi: 10.1097/AUD.0b013e3181cdb272.
    Results Reference
    result
    PubMed Identifier
    18400899
    Citation
    Johnson KL, Nicol T, Zecker SG, Kraus N. Developmental plasticity in the human auditory brainstem. J Neurosci. 2008 Apr 9;28(15):4000-7. doi: 10.1523/JNEUROSCI.0012-08.2008.
    Results Reference
    result
    PubMed Identifier
    34535280
    Citation
    Hood LJ. Auditory Neuropathy/Auditory Synaptopathy. Otolaryngol Clin North Am. 2021 Dec;54(6):1093-1100. doi: 10.1016/j.otc.2021.07.004. Epub 2021 Sep 15.
    Results Reference
    result
    PubMed Identifier
    7782180
    Citation
    Davis A, Fortnum H, O'Donoghue G. Children who could benefit from a cochlear implant: a European estimate of projected numbers, cost and relevant characteristics. Int J Pediatr Otorhinolaryngol. 1995 Mar;31(2-3):221-33. doi: 10.1016/0165-5876(94)01115-e.
    Results Reference
    result

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    Assessment of Children by Speech ABR

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