- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04595552
Language Development in Cochlear Implant Children
Language Profile of Cochlear Implanted Children at Assiut University, Egypt
The aim of this work is to assess language development in cochlear implanted children in Assiut university hospital and to assess the impact of some related factors (age of implantation, family motivation and education, age of hearing loss and the pre-implanted language therapy or pre-implanted hearing aid wearing) on this development.
Adoption of newborn hearing screening programs across the nations has resulted in early identification and confirmation of hearing losses in youngest and vulnerable populations. Early identification often results in early intervention using hearing technology assistance via hearing aids or cochlear implants, parental education programs, and speech-language therapy The major goal of intervention is to capitalize on providing sensory, motor, and interactive exchanges at the earliest stages of communication development as a means of reducing the deleterious effects of auditory deprivation
Study Overview
Detailed Description
A cochlear implant is a device that stimulates the auditory nerve electrically to produce hearing percepts. It has an external component that receives incoming sound, processes it according to a predefined strategy, and transfers the signal across the skin. A small, implanted electronic device receives and decodes the transmitted signal and stimulates electrodes in the cochlea. The electrodes stimulate the auditory nerve directly, bypassing the hair cells that implement the first stage of auditory neural processing in normal ears. The extended use of multichannel cochlear implants in adults brought about the first major success, both scientific and commercial, of a neural sensory prosthesis that replaced a human sense with an electronic device Cochlear implants are now widely used in young deaf children and have shown tremendous promise in facilitating a variety of developmental outcomes. Specifically, improvements have been shown in oral language, speech perception and recognition, attention, and behavioral development.
Medical advances, as well as technological inventions such as digital hearing aids and cochlear implants, have made significant changes in the likelihood that a child with hearing loss will achieve adequate speech perception, intelligible speech and language competency, though none of these is yet guaranteed for all children . Despite these advances, it is probable that a child with hearing loss faces a significant delay in exposure to auditory stimulation, leading to delays in the normal course of oral language development through audition. Research findings suggest that children who received an implant even before 12 months had a one year expressive language delay . Others found variable degrees of delay with children who received implants before age 2 of years.Others found that lowering the age of implantation does seem to improve the prospects of normal language acquisition but the evidence does not suggest that children with cochlear implants perform like hearing peers on average .
Most children who are born profoundly deaf or who become deaf before the age of 3 years fall significantly behind their normal-hearing peers in their mastery of the surrounding oral language in its written, read, spoken, and signed forms.
One of the most important factors shown to influence the development of communication abilities in pediatric cochlear implant recipients is age at time of implantation .
Children implanted by 12 months of age demonstrate better language development compared with children who receive their cochlear implant between 13 and 24 months. This supports the provision of a cochlear implant within the first year of life to enhance the likelihood that a child with severe-to-profound hearing impairment will commence elementary school with age-appropriate language skills. The implanted prior to 3 years had significantly faster rates of language development than later-implanted children.
Two additional demographic factors that influence communication development in children with cochlear implants are communication mode and residual hearing. Children with prelingual deafness who use oral communication generally achieve significantly higher levels of speech perception, speech production, and/or language skills than their deaf peers who use total communication, that is, the combined use of signed and spoken language Speech perception performance with cochlear implants appears related to several factors. Higher speech perception appears linked to shorter periods of auditory deprivation, greater amounts of residual hearing, and younger ages of implantation Spoken language performance was related to the age the hearing loss was identified and the amount of typical hearing experience a child might have before losing their residual hearing
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt
- Medecine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All these patients have satisfactory threshold of hearing post operatively proved by full post-operative audiological evaluation.
-
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
Children with cochlear implant were given Auditory training and language therapy
|
auditory training and language therapy for 6 months up to 2 years in 2 session per week the duration of session 30 minuets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of expressive language in cochlear implant children
Time Frame: pre therapy
|
expressive language score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey 2004 in continuous number, higher value 100 and lower value 0, higher value is better outcome
|
pre therapy
|
|
assessment of receptive language in cochlear implant children
Time Frame: pre therapy
|
receptive language score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey 2004 in continuous number, higher value 100 and lower value 0, higher value is better outcome
|
pre therapy
|
|
semantics score in language test in The continuous number
Time Frame: pre therapy
|
semantics score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey 2004 in continuous number, higher value 100 and lower value 0, higher value is better outcome
|
pre therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of expressive language in cochlear implant children
Time Frame: An average of 1 year post therapy
|
expressive language score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey in continuous number, higher value 100 and lower value 0, higher value mean better outcome
|
An average of 1 year post therapy
|
|
assessment of receptive language in cochlear implant children
Time Frame: An average of 1 year post therapy
|
receptive language score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey in continuous number, higher value 100 and lower value 0, higher value mean better outcome
|
An average of 1 year post therapy
|
|
semantics score in language test in continuous number
Time Frame: An average of 1 year post therapy
|
semantics score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey 2004 in continuous number, higher value 100 and lower value 0, higher value 100 and lower value 0
|
An average of 1 year post therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abdallah Abdelzaher, Dr, Assiut University
Publications and helpful links
General Publications
- Levitt H, McGarr N, Geffner D. Development of language and communication skills in hearing-impaired children. Introduction. ASHA Monogr. 1987 Oct;(26):1-8. No abstract available.
- Moeller MP, Osberger MJ, Eccarius M. Language and learning skills of hearing-impaired students. Receptive language skills. ASHA Monogr. 1986 Mar;(23):41-53. No abstract available.
- Osberger MJ, Moeller MP, Eccarius M, Robbins AM, Johnson D. Language and learning skills of hearing-impaired students. Expressive language skills. ASHA Monogr. 1986 Mar;(23):54-65. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Development
-
Bartosz M. RadtkeRecruitingChild Development | Infant Development | Early Childhood DevelopmentPoland
-
Children's Hospital of PhiladelphiaNational Institute on Minority Health and Health Disparities (NIMHD)CompletedDevelopment Delay | Development, ChildUnited States
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...UnknownCognitive Development | Emotional DevelopmentUnited States
-
Central Hospital, Nancy, FranceCompletedDisease | Child Development | Denial (Psychology) | Personality DevelopmentFrance
-
Bundang CHA HospitalCompletedDelayed;Development;Physical | Delayed; Development, Intellectual
-
Swiss Tropical & Public Health InstituteSwiss National Science Foundation; University of Sao Paulo; Federal University... and other collaboratorsRecruitingDevelopment, Infant | Breastfeeding | Development, Child | Breast Feeding, ExclusiveBrazil
-
University of California, IrvineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingChild Development | Brain Development | Household and Family ProcessesUnited States
-
University of PennsylvaniaActive, not recruitingParenting | Child Development | Brain Development | Household and FamilyUnited States
-
SangathUNICEFCompletedChild Development | Child Nutrition and Early Child DevelopmentIndia
-
Yale UniversityRobinhood Foundation; Adelphi University; Docs for TotsCompletedSocial Skills | Child Behavior | Child Development | Infant DevelopmentUnited States
Clinical Trials on language therapy
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
-
University College, LondonCompletedLanguage Difficulties in British Sign Language
-
Johns Hopkins UniversityNational Institutes of Health (NIH); National Institute on Deafness and Other...CompletedPrimary Progressive Aphasia | MCI | FTDUnited States
-
Johns Hopkins UniversityWithdrawnPrimary Progressive AphasiaUnited States
-
Samsung Medical CenterCompletedStroke | Rehabilitation | LanguageKorea, Republic of
-
Charite University, Berlin, GermanyGerman Federal Ministry of Education and ResearchUnknownPost-Stroke Chronic Aphasia | Anomia (Word-retrieval Impairment)Germany
-
University of BirminghamRecruitingStroke | AphasiaUnited Kingdom
-
Johns Hopkins UniversityCompletedPrimary Progressive Aphasia | PPAUnited States
-
Shirley Ryan AbilityLabNorthwestern UniversityCompleted