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