Objective Measures in Cochlear Implant
1 other identifier
observational
30
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Dec 2017
Typical duration for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedAugust 24, 2017
August 1, 2017
1.7 years
August 20, 2017
August 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Arabic language test
Speech and language assessment in children with cochlear implant
2 years
Study Arms (1)
children with cochlear implant
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
Interventions
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 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
Eligibility Criteria
children with sensorineural hearing loss implanted with Medel multi-channel cochlear implant aged 2-6 years
You may qualify if:
- children implanted with Medel multichannel cochlear implant
You may not qualify if:
- Any middle ear problem
- Any technical problems with the cochlear implant device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director
Study Record Dates
First Submitted
August 20, 2017
First Posted
August 24, 2017
Study Start
December 1, 2017
Primary Completion
August 31, 2019
Study Completion
December 30, 2019
Last Updated
August 24, 2017
Record last verified: 2017-08