- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03260374
Objective Measures in Cochlear Implant
22. august 2017 opdateret af: Dina Mohamed, Assiut University
Objective Measures in Cochlear Implant in Children and Its Correlation to Outcome
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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
30
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 6 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
children with sensorineural hearing loss implanted with Medel multi-channel cochlear implant aged 2-6 years
Beskrivelse
Inclusion Criteria:
- children implanted with Medel multichannel cochlear implant
Exclusion Criteria:
• Any middle ear problem
- Any technical problems with the cochlear implant device
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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:-
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Arabic language test
Tidsramme: 2 years
|
Speech and language assessment in children with cochlear implant
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. december 2017
Primær færdiggørelse (Forventet)
31. august 2019
Studieafslutning (Forventet)
30. december 2019
Datoer for studieregistrering
Først indsendt
20. august 2017
Først indsendt, der opfyldte QC-kriterier
22. august 2017
Først opslået (Faktiske)
24. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OMCI
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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