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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Medecine

    Asyut

Other trials in Egypt

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

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 groups in NCT04595552
Study groupRoleWhat they receive
Study groupExperimentalChildren 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted20 Oct 2020
  2. Study startJul 2016
  3. Primary completionOct 2019
  4. Study completionDec 2019

Resources

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)
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 3509663
  • 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.

    PubMed 3730031
  • 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.

    PubMed 3730032

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.

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