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Bimodal Stimulation Compared to Unilateral Cochlear Implant

Primary Purpose

Hearing Impaired Children

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hearing aid
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Impaired Children focused on measuring Hearing Loss

Eligibility Criteria

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

Inclusion Criteria:

  1. The lack of middle-ear infection.
  2. Normative intelligence.
  3. The lack of auditory neuropathy disorder .
  4. Residual hearing in the non-implanted ear.

Exclusion Criteria:

  1. Middle ear infection..
  2. Below average intelligence.
  3. Auditory neuropathy disorder.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pre-lingually deafened children with cochlear implant

    Arm Description

    pre-lingually deafened children with cochlear implant who continuously used bimodal hearing.

    Outcomes

    Primary Outcome Measures

    Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition
    By using pure tone and speech audiometer the pure tone audiometry will be done in the free field with a speaker at 0° azimuth and the mean threshold in speech frequencies of 0.5, 1, 2 and 4 kilohertz will be determined.
    Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.
    The speech discrimination score is a measure as a percentage of words from a standardized list presented at suprathreshold levels that are recognized and repeated by the patient. a higher score on the speech discrimination test is better Interpreting speech discrimination score : 100-90% Means Excellent or Normal speech discrimination score, 89-75% Means Good speech discrimination score, 74-60% Means Fair speech discrimination score, 59-50 % Means Poor speech discrimination score& <50% Means Very Poor speech discrimination score.
    Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition
    By speech perception in noise (SPIN) test using Compact disc on compact discs player.
    Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition
    The test will be done starting from a low level using the manual and standard scoring forms of Early speech perception test ( ESP) by using : Compact disc , full-color picture cards, Toys ,digitally remastered sounds, and an All Words menu
    Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.
    Speech reception threshold is the minimum intensity in decibels at which a patient can understand 50% of spoken words from a closed set list of disyllabic words

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2019
    Last Updated
    January 16, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04093830
    Brief Title
    Bimodal Stimulation Compared to Unilateral Cochlear Implant
    Official Title
    Advantages of Bimodal Stimulation Compared to Unilateral Cochlear Implant Use in Children With Hearing Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    January 1, 2022 (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

    5. Study Description

    Brief Summary
    The majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural hearing loss .
    Detailed Description
    There are now many recipients of unilateral cochlear implants who have usable residual hearing in the non-implanted ear. To avoid auditory deprivation and to provide binaural hearing, a hearing aid or a second cochlear implant can be fitted to that ear. When bilateral cochlear implant cannot be used for patients with bilateral hearing impairment, a hearing aid can be used in their non- implanted ear with residual hearing. This is because patients with bilateral hearing loss need bilateral stimulation to develop the neural pathway required for central processing of binaural hearing.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pre-lingually deafened children with cochlear implant
    Arm Type
    Experimental
    Arm Description
    pre-lingually deafened children with cochlear implant who continuously used bimodal hearing.
    Intervention Type
    Device
    Intervention Name(s)
    hearing aid
    Intervention Description
    hearing aid can be used in their non- implanted ear with residual hearing
    Primary Outcome Measure Information:
    Title
    Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition
    Description
    By using pure tone and speech audiometer the pure tone audiometry will be done in the free field with a speaker at 0° azimuth and the mean threshold in speech frequencies of 0.5, 1, 2 and 4 kilohertz will be determined.
    Time Frame
    Baseline
    Title
    Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.
    Description
    The speech discrimination score is a measure as a percentage of words from a standardized list presented at suprathreshold levels that are recognized and repeated by the patient. a higher score on the speech discrimination test is better Interpreting speech discrimination score : 100-90% Means Excellent or Normal speech discrimination score, 89-75% Means Good speech discrimination score, 74-60% Means Fair speech discrimination score, 59-50 % Means Poor speech discrimination score& <50% Means Very Poor speech discrimination score.
    Time Frame
    Baseline
    Title
    Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition
    Description
    By speech perception in noise (SPIN) test using Compact disc on compact discs player.
    Time Frame
    Baseline
    Title
    Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition
    Description
    The test will be done starting from a low level using the manual and standard scoring forms of Early speech perception test ( ESP) by using : Compact disc , full-color picture cards, Toys ,digitally remastered sounds, and an All Words menu
    Time Frame
    Baseline
    Title
    Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.
    Description
    Speech reception threshold is the minimum intensity in decibels at which a patient can understand 50% of spoken words from a closed set list of disyllabic words
    Time Frame
    Baseline

    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: The lack of middle-ear infection. Normative intelligence. The lack of auditory neuropathy disorder . Residual hearing in the non-implanted ear. Exclusion Criteria: Middle ear infection.. Below average intelligence. Auditory neuropathy disorder.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mariam R Fam, Resident
    Phone
    01008630890
    Email
    mariamrizkfam@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amira M Eloseily, Lecturer
    Phone
    01095495110
    Email
    amiraos@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Enass S Mohamed, Professor
    Organizational Affiliation
    Professor of Audio-vestibular medicine,Assiut University,Egypt.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18057874
    Citation
    Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiol Neurootol. 2008;13(2):105-12. doi: 10.1159/000111782. Epub 2007 Nov 29.
    Results Reference
    background
    PubMed Identifier
    24437856
    Citation
    Kokkinakis K, Pak N. Binaural advantages in users of bimodal and bilateral cochlear implant devices. J Acoust Soc Am. 2014 Jan;135(1):EL47-53. doi: 10.1121/1.4831955. Erratum In: J Acoust Soc Am. 2014 May;135(5):3127.
    Results Reference
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    PubMed Identifier
    29451107
    Citation
    Tao DD, Liu JS, Yang ZD, Wilson BS, Zhou N. Bilaterally Combined Electric and Acoustic Hearing in Mandarin-Speaking Listeners: The Population With Poor Residual Hearing. Trends Hear. 2018 Jan-Dec;22:2331216518757892. doi: 10.1177/2331216518757892.
    Results Reference
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    Learn more about this trial

    Bimodal Stimulation Compared to Unilateral Cochlear Implant

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