LanguageNCT04595552
Language Development in Cochlear Implant Children
A study testing language therapy in people with Language and Development, run by Assiut University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Language, Development
- What is being tested?
- language therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All these patients have satisfactory threshold of hearing post operatively proved by full post-operative audiological evaluation.
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Language, Development
- Being tested
- language therapy
- Keywords
- language, cochlear, implant
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
language therapyOther
auditory training and language therapy for 6 months up to 2 years in 2 session per week the duration of session 30 minuets
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Children with cochlear implant were given Auditory training and language therapy Receives: Other: language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of expressive language in cochlear implant children
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
Measured: pre therapy
assessment of receptive language in cochlear implant children
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
Measured: pre therapy
semantics score in language test in The continuous number
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
Measured: pre therapy
Secondary outcomes (3)
assessment of expressive language in cochlear implant children
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
Measured: An average of 1 year post therapy
assessment of receptive language in cochlear implant children
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
Measured: An average of 1 year post therapy
semantics score in language test in continuous number
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
Measured: An average of 1 year post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study startJul 2016
- Primary completionOct 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LanguageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional prospective study
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Metwally Abdelzaher, Assiut University
- Investigators
- Abdallah Abdelzaher, Dr, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595552
- Sponsor's protocol ID
- Language in cochlear implant
- Status last verified
- Oct 2020
- First submitted
- 25 Sep 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 3509663Moeller 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.
PubMed 3730031Osberger 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.
PubMed 3730032
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language Profile of Cochlear Implanted Children at Assiut University, Egypt
- ClinicalTrials.gov ID
- NCT04595552
- Acronym / sponsor ID
- Language in cochlear implant
- Conditions
- Language, Development
- Keywords
- language, cochlear, implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional prospective study
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: language therapyChildren with cochlear implant were given Auditory training and language therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All these patients have satisfactory threshold of hearing post operatively proved by full post-operative audiological evaluation.
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| language therapyauditory training and language therapy for 6 months up to 2 years in 2 session per week the duration of session 30 minuets | Other | Study group |
Primary outcome
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
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
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
3 secondary outcomes
assessment of expressive language in cochlear implant children
Time frame: An average of 1 year post therapy
assessment of receptive language in cochlear implant children
Time frame: An average of 1 year post therapy
semantics score in language test in continuous number
Time frame: An average of 1 year post therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Background: PubMed 3509663Levitt 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.
- Background: PubMed 3730031Moeller 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.
- Background: PubMed 3730032Osberger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdallah Abdelzaher, Dr principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing language therapy in people with Language and Development, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of expressive language in cochlear implant children (time frame: pre therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595552, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.