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Speech Cortex DisorderNCT03719963

Preoperative Variables Affecting Outcome Of Cochlear Implant

An observational study of Speech Cortex Disorder, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cochlear implants (CIs) represent one of the most important achievements of modern medicine as, for the first time in history, an electronic device is able to restore a lost sense - hearing. As of December 2012, approximately 324,200 cochlear implants have been implanted worldwide. Read more about this study

Who is it for?
Ages Up to 6 years
Conditions the study is for
Speech Cortex Disorder
What is being tested?
Cochlear implant
Type of treatment
Medical device
How many people
40 participants
Where
No sites listed yet
Study dates
1 Dec 2018to Jun 2019
Phase
Observational
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 Up to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Age less than 6years at time of implantation with history of cochlear implant

Who may be able to join

  • a) Children with bilateral severe to profound sensorineural hearing loss. b) Age less than 6 years at time of implantation. c) Prelingual deafness

Who cannot join

  • Incomplete follow up.
  • post lingual children
  • children with special needs such as mental retardation or autism

Trial locations and contacts

No sites are listed yet.

Nashwa Mr Ameer Mahmoud, Master contact

00201000445830

Nashwa_ameer88@yahoo.com

About this study

Cochlear implants (CIs) represent one of the most important achievements of modern medicine as, for the first time in history, an electronic device is able to restore a lost sense - hearing. As of December 2012, approximately 324,200 cochlear implants have been implanted worldwide. In the United States, roughly 58,000 devices have been implanted in adults and 38,000 in children .

The aim of this study is to assess the factors affecting the audiological, speech and language outcomes achieved by the recipients of multi-channel cochlear implants.

Read the detailed description

Cochlear implants (CIs) represent one of the most important achievements of modern medicine as, for the first time in history, an electronic device is able to restore a lost sense - hearing. As of December 2012, approximately 324,200 cochlear implants have been implanted worldwide. In the United States, roughly 58,000 devices have been implanted in adults and 38,000 in children .

Cochlear implantation is a powerful tool for helping children with severe to profound sensorineural hearing loss to gain the ability to hear, and to achieve age appropriate communication skills. Evaluating the development of auditory, speech, language skills and the personality of implanted child is useful for the parent, the teacher, the therapist, and the subsequent rehabilitation progress .

However the final outcome in pediatric implantation is yet not entirely predictable as there are a large number of factors which alone or in combination will decide the outcome of cochlear implantation.

Categorizing these determinants increases the ability of clinicians to offer educated preoperative prognosis and might potentially allow for manipulation of variables in an attempt to achieve the best possible outcome .

Before implantation, a trial period with appropriate amplification combined with intensive auditory training should be attempted to ensure that maximal benefit is achieved.

Several factors have been reported to have an impact on the ability of prelingually deaf children to develop oral language skills after cochlear implantation. The most important and consistently reported variable that influences the ability to use auditory-only communication is the age at which the child is implanted .

Communication mode after implantation has also been frequently reported to be a factor that contributes to final speech and language outcome, with oral-only communication producing speech and language results superior to those observed in children who use a combination of sign and spoken language (total communication).

The wide range of speech perception abilities exhibited by cochlear implant recipients may depend in part upon differences in the central auditory processing abilities of implant users. One way to assess central auditory function in these individuals is to measure speech evoked cortical potentials. In particular, measuring cortical potentials that reflect auditory discrimination may provide insight into the central mechanisms underlying speech perception .

Moreover, if those cortical potentials can be recorded from cochlear implant users, comparing the potentials to the responses measured in normal listeners should indicate whether the brain's response to speech mediated by a cochlear implant is similar to the brain's response to speech processed by a normal cochlea. From a theoretical standpoint, the presence of cortical potentials in cochlear implant users may provide a unique window to viewing the central auditory system.

Aim of the study:

The aim of this study is to assess the factors affecting the audiological, speech and language outcomes achieved by the recipients of multichannel cochlear implants.

Being tested
Cochlear implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cochlear implantDevice

    Cochlear implant for hearing process by surgical intervention

Study groups in NCT03719963
Study groupRoleWhat they receive
cochlear implantCochlear implantation is a powerful tool for helping children with severe to profound sensorineural hearing loss to gain the ability to hear, and to achieve age appropriate communication skills. Evaluating the development of auditory, speech, language skills and the personality of implanted child is useful for the parent, the teacher, the therapist, and the subsequent rehabilitation progress
Receives: Device: Cochlear implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. speech cortical evoked potential

    Intelligent hearing system is the name of the instrument that will be used,speech stimulus that will used,cortical p1 and N1 waves that will be detected which is the outcome that we need to measure

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start1 Dec 2018 (estimated)
  3. Primary completionApr 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03719963
Sponsor's protocol ID
17200178I
Status last verified
Oct 2018
First submitted
2 Jun 2018
Last updated
25 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: yes i agree to share the research plan

Publications

  • Holt RF, Svirsky MA. An exploratory look at pediatric cochlear implantation: is earliest always best? Ear Hear. 2008 Aug;29(4):492-511. doi: 10.1097/AUD.0b013e31816c409f.

    PubMed 18382374

Questions about this trial

What is this clinical trial studying?

An observational study of Speech Cortex Disorder, run by Assiut University.

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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nashwa Mr Ameer Mahmoud, Master (00201000445830, Nashwa_ameer88@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

speech cortical evoked potential (time frame: 1 year). 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 NCT03719963, which also lists 1 linked publication.

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 25 Oct 2018.

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