Improving Cochlear Implant Outcomes Through Modeling and Programming Strategies Based on Human Inner Ear Pathology
29 de junio de 2026 actualizado por: Julie G. Arenberg, CCC-A, Massachusetts Eye and Ear Infirmary
Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.
This study looks at whether customizing the way a cochlear implant is programmed, based on the health of the hearing nerve in different areas of the ear, can help people understand speech better in noisy settings. The researchers will adjust or turn off certain electrodes in areas where the nerve appears weaker, then test whether this improves hearing compared to each person's everyday program. They will also examine whether giving people time to get used to the new program leads to better results.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Cochlear implants are surgically placed in the inner ears of people with severe to profound hearing loss. Although these devices are generally successful, outcomes differ a great deal from one person to the next. Many people who use cochlear implants continue to struggle with understanding speech when there is background noise and with appreciating music. More research is needed to understand why results vary so much among cochlear implant users.
The main goal of this study is to better understand the underlying condition of the inner ear and how it relates to how well people hear with their cochlear implant. The researchers will use this knowledge to test new ways of programming the devices. A cochlear implant has multiple electrodes, and each one stimulates a different region of the hearing nerve. In some people, certain regions of the nerve are healthier than others. By estimating where the nerve is weaker or stronger, the researchers hope to program the device in a way that takes advantage of the healthier areas.
The study has one main aim with two parts:
The first part compares how well participants understand speech in noise using their usual everyday program versus an experimental program. In the experimental program, the electrical signal is narrowed and focused for electrodes that are farther from healthy nerve regions, and electrodes near poorly functioning nerve regions may be turned off. These adjustments are guided by a model of nerve health developed in earlier research.
The second part looks at whether performance improves after participants spend four weeks getting used to the experimental program. The researchers expect that programming based on each person's individual nerve health will improve their ability to understand speech in noise, and that this improvement will be greater after they have had time to adjust to the new program.
This work is expected to provide a better understanding of how long a person needs to adapt when their programming strategy changes. The findings could be applied fairly quickly in clinical settings to improve speech understanding for both adults and children who use cochlear implants.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
45
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Julie Arenberg, PhD, CCC-A
- Número de teléfono: 617-807-7904
- Correo electrónico: julie_arenberg@meei.harvard.edu
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 18 - 80 years old
- Native speakers of American English or Multilingual
- Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer)
- At least 6 months of listening experience with their cochlear implant, but could be recruited and consented prior.
- Bilateral hearing loss
Exclusion Criteria:
- Inability to provide informed consent
- Lost their hearing prior to the age of language acquisition (3-4 years) but did not receive a cochlear implant until adulthood
- Do not have age-appropriate speech perception testing from clinical visits or do not use their implant for oral communication
- Have neurological disease
- Have unmanageable facial nerve stimulation or pain as a result of their implant
- Does not tolerate implant well
- Unable to carry out the study protocol or tasks required in the study
- Poor vision such that the subject cannot adequately perform the study tasks on the computer screen
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
1
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: All Participants (Within-Subjects Crossover)
This is a within-subjects study in which all enrolled participants receive every condition. Each participant's everyday clinical listening program serves as the control and is compared against two experimental sound-processing strategies based on electrode-neuron interface (ENI) estimates. In the in-lab phase (Sub-Aim 1.1), all programs are compared acutely. In the take-home phase (Sub-Aim 1.2), participants complete a 12-week crossover consisting of 4 weeks with their clinical program followed by 4 weeks with each experimental strategy, with the order of programs randomized. |
The participant's standard clinical cochlear implant sound-processing program, as currently fit for everyday use.
This serves as the within-subjects control condition and remains available as a backup throughout the take-home trial.
An experimental cochlear implant sound-processing strategy that applies focused electrical fields for electrodes distant from regions of healthy neural tissue and/or deactivates channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model.
Tested acutely in the lab and during one 4-week take-home interval.
A second experimental cochlear implant sound-processing strategy applying focused electrical fields and/or channel deactivation based on electrode-neuron interface estimates, configured differently from Experimental Program 1. Tested acutely in the lab and during one 4-week take-home interval.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Sentence Recognition in Noise (Everyday Program vs. Experimental Programs), In-Lab
Periodo de tiempo: Across a minimum of two in-lab sessions (each up to 3.5 hours)
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Sentence recognition in background noise will be measured using the American Matrix Test (AMT), an adaptive, closed-set speech-in-noise test consisting of 4 blocks of 20 sentences each (5 words per sentence).
The adaptive procedure yields a speech reception threshold expressed in dB SNR, the signal-to-noise ratio at which the participant correctly identifies 50 percent of words, with lower (more negative) values indicating better performance.
Scores obtained with the participant's everyday clinical listening program (control) will be compared to scores obtained with two experimental sound-processing strategies that apply focused electrical fields for distant electrodes and/or deactivate channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model.
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Across a minimum of two in-lab sessions (each up to 3.5 hours)
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Change in Vowel Identification (Everyday Program vs. Experimental Programs), In-Lab
Periodo de tiempo: Across a minimum of two in-lab sessions (each up to 3.5 hours)
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Medial vowel identification will be measured using a closed-set vowel discrimination task in quiet and at a +10 dB signal-to-noise ratio in four-talker babble noise.
Performance is scored as percent correct, with higher values indicating better performance.
Scores obtained with the participant's everyday clinical program (control) will be compared to scores obtained with the two experimental sound-processing strategies.
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Across a minimum of two in-lab sessions (each up to 3.5 hours)
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Sentence Recognition in Noise After 4 Weeks of Acclimatization (Crossover)
Periodo de tiempo: Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
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Using a randomized crossover design, sentence recognition in noise (American Matrix Test) will be assessed before and after 4 weeks of at-home listening for the control program and each experimental program.
The adaptive procedure yields a speech reception threshold in dB SNR, with lower (more negative) values indicating better performance.
Participants complete 4 weeks of baseline testing with their clinical program followed by 4 weeks with each of the two experimental strategies.
The outcome is the change in score across time points and programs, evaluating the effect of acclimatization.
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Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
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Change in Vowel Identification After 4 Weeks of Acclimatization (Crossover)
Periodo de tiempo: Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
|
Using the randomized crossover design, medial vowel identification will be assessed before and after 4 weeks of at-home listening for the control and experimental programs.
Performance is scored as percent correct, with higher values indicating better performance.
The outcome evaluates the effect of acclimatization on performance.
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Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
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Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective Sound Quality Ratings
Periodo de tiempo: Baseline and weekly during the 12-week take-home trial
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Participants rate the sound quality of the listening programs using a custom Sound Quality Questionnaire administered at baseline and at weekly intervals throughout the take-home trial.
Results are reported as scores on the questionnaire's rating scale.
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Baseline and weekly during the 12-week take-home trial
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Electrically Evoked Compound Action Potential (ECAP)
Periodo de tiempo: Collected during in-lab sessions (each up to 3.5 hours)
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The Electrically Evoked Compound Action Potential (ECAP) will be recorded via telemetry to measure the auditory nerve's response to electrical stimulation delivered through the cochlear implant.
Response amplitude is reported in microvolts.
This measure helps characterize the electrode-neuron interface used to inform the experimental programming strategies.
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Collected during in-lab sessions (each up to 3.5 hours)
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Electrical Field Imaging (EFI)
Periodo de tiempo: Collected during in-lab sessions (each up to 3.5 hours)
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Electrical Field Imaging (EFI) will be recorded via telemetry to measure the distribution of electrical current within the cochlea where the implant electrodes are located.
Recorded voltages are reported in volts.
This measure helps characterize the electrode-neuron interface used to inform the experimental programming strategies.
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Collected during in-lab sessions (each up to 3.5 hours)
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Psychophysical Detection Threshold
Periodo de tiempo: Collected during in-lab sessions (each up to 3.5 hours)
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Detection threshold, defined as the softest level at which the participant can detect a stimulus, will be measured across multiple electrode configurations including monopolar and novel focused stimulation modes.
Thresholds are reported in clinical units (CU) as used for clinical device programming.
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Collected during in-lab sessions (each up to 3.5 hours)
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Maximum Comfortable Level (MCL)
Periodo de tiempo: Collected during in-lab sessions (each up to 3.5 hours)
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Maximum comfortable level, defined as the level that is loud but still comfortable, will be measured across multiple electrode configurations including monopolar and novel focused stimulation modes.
Levels are reported in clinical units (CU) as used for clinical device programming.
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Collected during in-lab sessions (each up to 3.5 hours)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Julie Arenberg, PhD, CCC-A, Massachusetts Eye and Ear
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
30 de julio de 2026
Finalización primaria (Estimado)
Finalización primaria
30 de julio de 2028
Finalización del estudio (Estimado)
Finalización del estudio
30 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
29 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
29 de junio de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
6 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
6 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
29 de junio de 2026
Última verificación
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2026P001659
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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