Aural Rehab for Adult CI Outcomes
A Phase I, Single-Center Study of the Effects of Aural Rehabilitation Protocols on Adult Cochlear Implant Outcomes
This study will compare two different types of aural rehabilitation schedules (computer-based auditory training vs computer based auditory training and clinician guided training) for adult cochlear implant (CI) users to determine the effect of rehabilitation type on speech perception, hearing related-quality of life, and CI management skills.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: J. Thomas Roland, Jr., MD
- Numéro de téléphone: 212-263-5565
- E-mail: J.Thomas.RolandJr@nyulangone.org
Lieux d'étude
-
-
New York
-
New York, New York, États-Unis, 10016
- NYU Langone Heath
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Be at least 18 years of age at the time of cochlear implantation.
- Receive pre- and post-CI care at the NYU Langone Health Cochlear Implant Center.
- Have bilateral hearing loss, with at least moderate to profound hearing loss in both ears.
- Be able to participate in follow-up visits, either in person or via synchronous telehealth, and to use an app-based training platform (ReDi).
- Be English-speaking or have native-like English proficiency.
Exclusion Criteria:
- Has significant cognitive impairment or a medical disability that precludes informed consent or reliable participation or develops such impairment during the study period.
- Has pre-lingual or long-term (>20 years) severe to profound hearing loss
- Is undergoing cochlear implantation for single-sided deafness.
- Is undergoing revision CI surgery.
- Is younger than 18 years of age.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Computer-Based Auditory Training
CI users assigned to receive computer-based auditory training only. |
Aural rehabilitation program delivered through an auditory training app. Each participant will be assigned to complete training 5 days per week, with each session being 15 minutes for the first 6 months post-activation. |
|
Expérimental: Computer-Based Auditory Training + Clinician-Guided Training
CI users assigned to receive computer-based auditory training and clinician-guided training. |
Aural rehabilitation program delivered through an auditory training app. Each participant will be assigned to complete training 5 days per week, with each session being 15 minutes for the first 6 months post-activation. Aural rehabilitation program delivered by a speech-language pathologist. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in CNC Word Recognition Score
Délai: Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Calculated as the percentage of words a person can hear, repeat back, and understand. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
|
Change in CNC Phoneme Recognition Score
Délai: Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Calculated as the percentage of individual phonemes (sounds) identified correctly out of 150 total phonemes. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
|
Change in AzBio Sentence Recognition Score
Délai: Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Standardized speech perception assessment used by audiologists to measure how well a person understands everyday conversational speech. Patients are evaluated on their ability to recognize words correctly in a sentence. Each sentence has a set number of key words assigned specific point values. The final score is calculated as a percentage of words correct out of the total possible words in the list. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in CIQOL35 Profile Score
Délai: Week 6 Post-Activation, Year 1 Post-Activation
|
Patient-reported outcome measure designed to evaluate real-world functional abilities and quality of life for adult cochlear implant (CI) users. Each item is rated on a Likert scale; the raw score is re-scaled into a total score from 0 (low quality of life/functional ability) to 100 (high quality of life/functional ability). |
Week 6 Post-Activation, Year 1 Post-Activation
|
|
Change in CIMS-Self
Délai: Week 6 Post-Activation, Year 1 Post-Activation
|
10-item self-administered assessment of how effectively a patient or caregiver handles and maintains a cochlear implant processor. Each response is rated from 0 to 3; the raw score is the sum of responses and is transformed to a percentage (0 - 100%); a score below 100% indicates a need for targeted training or retraining in specific maintenance areas. |
Week 6 Post-Activation, Year 1 Post-Activation
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: J. Thomas Roland, Jr., MD, NYU Langone Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
- 26-00880
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
No plan to make IPD available.
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
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