<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260374</url>
  </required_header>
  <id_info>
    <org_study_id>OMCI</org_study_id>
    <nct_id>NCT03260374</nct_id>
  </id_info>
  <brief_title>Objective Measures in Cochlear Implant</brief_title>
  <official_title>Objective Measures in Cochlear Implant in Children and Its Correlation to Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the main factors affecting the ability to maximize the full potential of a cochlear&#xD;
      implant is an accurate map.The goal of mapping is to enable cochlear implant recipients to&#xD;
      perceive a desired range of acoustic signals. The process includes programming of the minimum&#xD;
      and the maximum stimulation levels that are based on subjective measurements of thresholds&#xD;
      and the most comfortable level . The use of objective measures in the CI process has greatly&#xD;
      contributed to the definition of the dynamic field, as they provide specific values that&#xD;
      serve as the basis for the start of the mapping process, especially in cases of infants and&#xD;
      young children. Some examples of these measures are electrically evoked stapedius reflex&#xD;
      threshold , neural response telemetry , brainstem auditory evoked potential , and P300, among&#xD;
      others.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In adult Cochlear implant users, programming is a relatively straightforward task as&#xD;
      psychophysical measurements can be explained, and patients quickly understand the link&#xD;
      between the mapping process and the output of their system . In young children or infants,&#xD;
      the mapping process is more complex, especially comfort levels. Setting the threshold level&#xD;
      requires the child to respond to the presence or the absence of a sound. Although the same&#xD;
      techniques are used in setting the comfort level, the child is now required to make a&#xD;
      judgment about the sound beyond its simple presence or absence. Young children often lack the&#xD;
      attention span, patience, and cognitive and language skills necessary to perform these tasks&#xD;
      with good reliability and repeatability .The use of objective measures in the CI process has&#xD;
      greatly contributed to the definition of the dynamic field, as they provide specific values&#xD;
      that serve as the basis for the start of the mapping process, especially in cases of infants&#xD;
      and young children. Some examples of these measures are electrically evoked stapedius reflex&#xD;
      threshold , neural response telemetry , brainstem auditory evoked potential , and P300, among&#xD;
      others.The electrically evoked compound action potentials, which are closely related to the&#xD;
      electrically evoked brainstem responses, would also show a similar correlation with the&#xD;
      behavioral threshold . Determining threshold levels requires subjective responses to a series&#xD;
      of sophisticated psychophysical percepts. This is often difficult for cochlear implant&#xD;
      patients. However, the neural response telemetry system renders possible the measurement of&#xD;
      the compound action potential threshold . Electric stapedial reflex threshold measurements&#xD;
      are performed using the same software platform and electrical stimulus utilized for fitting&#xD;
      the cochlear implant . Thus, stimulus parameters, including pulse duration and repetition&#xD;
      rate, can be identical to those used to obtain behavioral judgments for psychophysical levels&#xD;
      .For most implant recipients , even the first introduction of electric stimulation from a&#xD;
      cochlear implant evokes activity in the auditory brainstem , which can be measured as clear&#xD;
      electric auditory brain stem response waveforms . Therefore this test can be used in the&#xD;
      functional evaluation of the auditory system between the time of initial implant activation&#xD;
      and after chronic cochlear implant use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Arabic language test</measure>
    <time_frame>2 years</time_frame>
    <description>Speech and language assessment in children with cochlear implant</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sensorineural Hearing Loss</condition>
  <arm_group>
    <arm_group_label>children with cochlear implant</arm_group_label>
    <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:-&#xD;
Electric compound action potential&#xD;
Electric stapedial reflex threshold&#xD;
Electric auditory brain stem response</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electric compound action potential</intervention_name>
    <description>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 .</description>
    <arm_group_label>children with cochlear implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>electric stapedial reflex threshold</intervention_name>
    <description>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</description>
    <arm_group_label>children with cochlear implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>electric auditory brain stem response</intervention_name>
    <description>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 the electric auditory brain stem response 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</description>
    <arm_group_label>children with cochlear implant</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        children with sensorineural hearing loss implanted with Medel multi-channel cochlear&#xD;
        implant aged 2-6 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children implanted with Medel multichannel cochlear implant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Any middle ear problem&#xD;
&#xD;
               -  Any technical problems with the cochlear implant device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Dina Mohamed</investigator_full_name>
    <investigator_title>director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260374
org study id: OMCI
nct id: NCT03260374
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Arabic language test
time frame: 2 years
description: Speech and language assessment in children with cochlear implant
arm group label: 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
intervention type: Device
intervention name: Electric compound action potential
description: 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 .
arm group label: children with cochlear implant
intervention type: Device
intervention name: electric stapedial reflex threshold
description: 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
arm group label: children with cochlear implant
intervention type: Device
intervention name: electric auditory brain stem response
description: 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 the electric auditory brain stem response 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
arm group label: children with cochlear implant
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Dina Mohamed
investigator title: director
mesh term: Hearing Loss
mesh term: Hearing Loss, Sensorineural