- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
pre lingual
aided response, speech perception threshold impedance telemetry electrically evoked action potential p1n1 cortical evoked potential
|
aided response, speech, evoked potential
Autres noms:
|
|
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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hearing threshold for Cochlear implant users at Sohag University Hospital
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shahenda A Moussa, Master, Sohag university, Faculty of medicine
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Soh-Med-21-01-06
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .