Objective Measures in Cochlear Implant

Brief Title

Objective Measures in Cochlear Implant

Official Title

Objective Measures in Cochlear Implant in Children and Its Correlation to Outcome

Brief Summary

      One of the main factors affecting the ability to maximize the full potential of a cochlear
      implant is an accurate map.The goal of mapping is to enable cochlear implant recipients to
      perceive a desired range of acoustic signals. The process includes programming of the minimum
      and the maximum stimulation levels that are based on subjective measurements of thresholds
      and the most comfortable level . The use of objective measures in the CI process has greatly
      contributed to the definition of the dynamic field, as they provide specific values that
      serve as the basis for the start of the mapping process, especially in cases of infants and
      young children. Some examples of these measures are electrically evoked stapedius reflex
      threshold , neural response telemetry , brainstem auditory evoked potential , and P300, among
      others.
    

Detailed Description

      In adult Cochlear implant users, programming is a relatively straightforward task as
      psychophysical measurements can be explained, and patients quickly understand the link
      between the mapping process and the output of their system . In young children or infants,
      the mapping process is more complex, especially comfort levels. Setting the threshold level
      requires the child to respond to the presence or the absence of a sound. Although the same
      techniques are used in setting the comfort level, the child is now required to make a
      judgment about the sound beyond its simple presence or absence. Young children often lack the
      attention span, patience, and cognitive and language skills necessary to perform these tasks
      with good reliability and repeatability .The use of objective measures in the CI process has
      greatly contributed to the definition of the dynamic field, as they provide specific values
      that serve as the basis for the start of the mapping process, especially in cases of infants
      and young children. Some examples of these measures are electrically evoked stapedius reflex
      threshold , neural response telemetry , brainstem auditory evoked potential , and P300, among
      others.The electrically evoked compound action potentials, which are closely related to the
      electrically evoked brainstem responses, would also show a similar correlation with the
      behavioral threshold . Determining threshold levels requires subjective responses to a series
      of sophisticated psychophysical percepts. This is often difficult for cochlear implant
      patients. However, the neural response telemetry system renders possible the measurement of
      the compound action potential threshold . Electric stapedial reflex threshold measurements
      are performed using the same software platform and electrical stimulus utilized for fitting
      the cochlear implant . Thus, stimulus parameters, including pulse duration and repetition
      rate, can be identical to those used to obtain behavioral judgments for psychophysical levels
      .For most implant recipients , even the first introduction of electric stimulation from a
      cochlear implant evokes activity in the auditory brainstem , which can be measured as clear
      electric auditory brain stem response waveforms . Therefore this test can be used in the
      functional evaluation of the auditory system between the time of initial implant activation
      and after chronic cochlear implant use.
    

Study Type

Observational

Primary Outcome

Arabic language test

Condition

Sensorineural Hearing Loss

Intervention

Electric compound action potential

Study Arms / Comparison Groups

 children with cochlear implant

Description:  30 subjects whose age ranges from 2-6 years old who are implanted with Medel multichannel cochlear implant male and female will be included and will undergo:-
Electric compound action potential
Electric stapedial reflex threshold
Electric auditory brain stem response

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

30

Start Date

December 1, 2017

Completion Date

December 30, 2019

Primary Completion Date

August 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  children implanted with Medel multichannel cochlear implant

        Exclusion Criteria:

          -  • Any middle ear problem

               -  Any technical problems with the cochlear implant device
      

Gender

All

Ages

2 Years - 6 Years

Accepts Healthy Volunteers

No

Contacts

, , 

NCT ID

NCT03260374

Organization ID

OMCI

Responsible Party

Principal Investigator

Study Sponsor

Assiut University

Study Sponsor

, , 

Verification Date

August 2017