- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04719728
Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital
Assessment of Audiological Outcome of Cochlear Implant Program at Sohag University Hospital
Evaluation of the outcome of cochlear implantation (CI) is very important issue since adequate hearing is linked to improved communication outcomes and school performance, development of speech and language, enhances speech perception in quiet and noise and even allows CI recipients to use the telephone.
As well as there is a growing need for a widely used set of international quality standards on minimal outcome measurements to determine outcomes in CI recipients, monitor the auditory progress of CI recipients over time and to be able to relate on important issues as the most ideal age for implantation and the cut-off audiological thresholds for CI indication.
This study will be conducted to evaluate outcome of cochlear implantation in sohag university hospital.
Aim of work:
To evaluate the outcome of cochlear implantation in Sohag university hospital.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Materials and Methods:
- It is a prospective study on cochlear implant recipients in sohag cochlear implant unite from 2014: 2020.
• Subjects: Cochlear implant recipients in sohag cochlear implant unite from 2014: 2020.
Subjects will be divided into 2 categories:
Prelingual patients: subdivided into 3 groups
- Cochlear implant recipient with no medical or radiological issues.
- Cochlear implant recipients with medical concern or with other disabilities as syndromic patients.
- Cochlear implant recipients with radiological issues.
Postlingual patients: subdivided into 3 groups
- Cochlear implant recipients with no medical or radiological issues.
- Cochlear implant recipients with medical concern or with other disabilities as syndromic patients.
- Cochlear implant recipients with radiological issues.
Inclusion criteria:
Patients who received cochlear implant at Sohag university hospital and fulfill the following criteria:
- Age: from one year up to 60.
- Prelingual who had one year of regular speech therapy
Postlingual patients.
• Method:
Background information:
- History: Age, gender, Age at which hearing loss occur, cause of hearing loss, duration of hearing loss.
- Family support.
- Expectation of patient (if post lingual patient).
- Expectation of parents.
- Hearing assessment:
- Aided Pure Tone Audiometry (PTA) level.
Speech perception
- speech perception threshold (SRT).
- Speech perception in quiet for patients who developed language and postlingual patients using phonetically Balanced words for kinder garden ( PBKG) words, phonetically balanced words for adult (PBA), word intelligibility by picture identification (WIPI) or minimal birds.
Speech in noise test: for patients who developed language and post lingual patients.
3- Impedance telemetry. 4- Electrically evoked action potential (ECAP). 5- Cortical evoked P1N1 potential. Informed written consent will be taken from all Participant patients or their legal guardians.
This search will submit for approval from Research Ethics committee of Sohag Faculty of medicine.
All investigation will be done cost free.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
-
Patients who received cochlear implant at Sohag university hospital and fulfill the following criteria:
- Age: from one year up to 60.
- Prelingual who had one year of regular speech therapy
- Postlingual patients.
Exclusion Criteria:
- none
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
pre lingual
aided response, speech perception threshold impedance telemetry electrically evoked action potential p1n1 cortical evoked potential
|
aided response, speech, evoked potential
Altri nomi:
|
|
post lingual
aided response, speech perception threshold speech in noise impedance telemetry electrically evoked action potential p1n1 cortical evoked potential
|
aided response, speech, evoked potential
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hearing threshold for Cochlear implant users at Sohag University Hospital
Lasso di tempo: one year postoperative
|
Pure Tone Audiometery will be used to measure the hearing threshold in decible at each frequnecy from 250 Hz to 8000 Hz
|
one year postoperative
|
|
Central processing of speech for cochlear implant users at Sohag university Hospital
Lasso di tempo: one year postoperative
|
Auditory Evoked Potential for detection of P1 wave which generated at central auditory area, Presence of P1 wave means normal speech processing, while absence of P1 wave means abnormal speech processing
|
one year postoperative
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Shahenda A Moussa, Master, Sohag University, Faculty of Medicine
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Soh-Med-21-01-06
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .