CClinicalTrials.gg
Status unknownNCT03719963Updated Oct 25, 2018

Preoperative Variables Affecting Outcome Of Cochlear Implant

An observational study in Speech Cortex Disorder, sponsored by Assiut University. Status unknown. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2018-10-25.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
40
Ages
Up to 6 Years
Sex
All
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Study 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. 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.

02

Conditions studied

  • Speech Cortex Disorder
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • cochlear implant

    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

    Device: Cochlear implant

Interventions

  • DeviceCochlear implant

    Cochlear implant for hearing process by surgical intervention

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What researchers measure

Primary outcomes

  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

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: Yes — yes i agree to share the research plan

Supporting information: Sap, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03719963
Lead sponsor
Assiut University
Responsible party
Nashwa Ameer Mahmoud Mesaed (principle investigator, Assiut University) — Principal investigator
First posted
Oct 25, 2018
Start date
Dec 1, 2018 (estimated)
Primary completion
Apr 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Oct 25, 2018

Study contacts

Nashwa Mr Ameer Mahmoud, Master
Contact
Nashwa_ameer88@yahoo.com
00201000445830
Assiut university Faculty of medicine, University
study chair · www.emro.who.int/unified-medical -dictionary.html

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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