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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: J. Thomas Roland, Jr., MD
- Número de teléfono: 212-263-5565
- Correo electrónico: J.Thomas.RolandJr@nyulangone.org
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- NYU Langone Heath
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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. |
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Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in CNC Word Recognition Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in CIQOL35 Profile Score
Periodo de tiempo: 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
|
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Change in CIMS-Self
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: J. Thomas Roland, Jr., MD, NYU Langone Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-00880
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
No plan to make IPD available.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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