- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03260374
Objective Measures in Cochlear Implant
22 augusti 2017 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
30
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
2 år till 6 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
children with sensorineural hearing loss implanted with Medel multi-channel cochlear implant aged 2-6 years
Beskrivning
Inclusion Criteria:
- children implanted with Medel multichannel cochlear implant
Exclusion Criteria:
• Any middle ear problem
- Any technical problems with the cochlear implant device
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Arabic language test
Tidsram: 2 years
|
Speech and language assessment in children with cochlear implant
|
2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 december 2017
Primärt slutförande (Förväntat)
31 augusti 2019
Avslutad studie (Förväntat)
30 december 2019
Studieregistreringsdatum
Först inskickad
20 augusti 2017
Först inskickad som uppfyllde QC-kriterierna
22 augusti 2017
Första postat (Faktisk)
24 augusti 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 augusti 2017
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OMCI
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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