Objective Measures in Cochlear Implant

Related Clinical Trial
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss Dexamethasone-Eluting Cochlear Implant Electrode Artificial Intelligence in Diagnosis of DFNA9 Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC Cochlear Implant and Vestibular Function. Quality Control of CE-Certified Phonak Hearing Aids – 2018_42 Quality Control of CE-Certified Phonak Hearing Aids – 2018_28 Enlarged Vestibular Aqueduct Registry Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis Effectiveness of P02 Digital Hearing Aids ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population Genetic Analysis of Hereditary Disorders of Hearing and Balance Compassionate Use Arm – ABI541 ABI for 10 NF2 Patients Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life Evaluation of N6 Sound Processor in Group of Freedom Users Robotic Assisted Cochlear Implantation Feasibility Study Auditory Nerve Test System During Vestibular Schwannoma Resection Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors Listening Effort in Cochlear Implant Users Quality Control of CE-Certified Phonak Hearing Aids – 2019_19 Esteem Totally Implantable Hearing System A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy CI532 – Early Experience Study Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery Single-sided Deafness and Cochlear Implants Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques OTO-413 in Subjects With Speech-in-Noise Hearing Impairment The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure Clinical Evaluation of a Cochlear Implant System Objective Measures in Cochlear Implant Evaluation of a Binaural Spatialization Method for Hearing Aids Esteem New Subject Enrollment Post Approval Study Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss Investigation of Anatomical Correlates of Speech Discrimination Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts Balance in Children With Cochlear Implants Congenital Cytomegalovirus: Efficacy of Antiviral Treatment Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System Radiological Classification of the Facial Nerve Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial The Effect of Sound Stimulation on Hearing Ability The Effect of Sound Stimulation on Pure-tone Hearing Threshold Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss The SeaSHeL National Prospective Cohort Study Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions. Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode Video HIT in Sudden Sensorineural Hearing Loss Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss. FX-322 in Sensorineural Hearing Loss Autologous Bone Marrow Harvest and Transplant for Sensorineural Hearing Loss FX-322 in Adults With Stable Sensorineural Hearing Loss

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 Information


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

, , 



Administrative Informations


NCT ID

NCT03260374

Organization ID

OMCI


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

, , 


Verification Date

August 2017