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Cochlear Implantation and Social Outcomes

17 de junio de 2026 actualizado por: Janet Choi, University of Southern California

The goal of this clinical trial is to learn if hearing devices, like cochlear implants, affect social and cognitive function of older adults. The main questions the researchers want to answer are:

  • How social are older adults with hearing loss before and after using hearing devices?
  • How well do older adults with hearing loss think before and after using hearing devices?
  • For older adults who have hearing loss and use hearing devices, do changes in social interaction explain changes in how well they think (cognitive function)?
  • Do brainwaves (EEGs) in older adults with hearing loss change after using hearing devices?
  • Are there differences in how social older adults with hearing loss are compared to older adults without hearing loss?

What Participants Will Do:

  • Participants will take questionnaires for around 60 minutes. Questionnaires will ask participants about their background, health, hearing, and how social they are. Another set of questionnaires will check their thinking ability or cognition.
  • Participants will wear an audio sensor (TILES Audio Recorder on Jelly Mobile phone) for 2 weeks. The sensor will collect and store information about a participant's voice during conversations. Once the device has information about a participant's voice such as pitch and tone it will store this information and delete the audio recording. Words spoken during conversations will be deleted.
  • (Optional) Participants can choose to participate in a 45-60-minute EEG (electroencephalogram) recording session. Participants will have sensors placed on top of their heads. Sensors will record the participants' brainwaves. Sounds will be played to see how participants' brainwaves change when they hear sounds. Eligible participants will be invited to participate in 4-month follow-up study.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Estimado)

40

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

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90033
        • University of Southern California
        • Contacto:

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

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals.

Descripción

Inclusion Criteria:

  • Age >= 60 years
  • English or Spanish speaking
  • older adults with bilateral moderate to profound sensorineural hearing loss who are candidates for cochlear implants or have undergone cochlear implantation.

Exclusion Criteria:

  • Age <60 years
  • Unable to complete questionnaires in English or Spanish

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Adults with bilateral hearing loss (cochlear implant users or candidates)
Participants with bilateral moderate to profound hearing loss who are candidates for cochlear implant or currently using cochlear implants
Procedimiento: Cochlear implant
Participants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Audio sensor- speech arousal
Periodo de tiempo: Baseline, optional 4-month follow-up
The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech arousal measures include the percentage of strong arousals, serving as a proxy of enhanced engagement in conversations.
Baseline, optional 4-month follow-up
Audio sensor- speech activity
Periodo de tiempo: Baseline, optional 4-month follow-up
The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech activity measures include the intersession time (the interval between speech sessions, representing the frequency of conversation engagement).
Baseline, optional 4-month follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
UCLA Loneliness Scale
Periodo de tiempo: Baseline, optional 4 months follow-up
The UCLA Loneliness Scale is a 20-item self-report measure assessing subjective feelings of loneliness and social isolation. Total scores range from 20 to 80, with higher scores indicating greater loneliness and worse outcomes. Minimum score: 20; maximum score: 80. Higher scores represent worse outcomes.
Baseline, optional 4 months follow-up
Lubben Social Network Scale (LSNS-6)
Periodo de tiempo: Baseline, optional 4 months follow-up
The Lubben Social Network Scale (LSNS-6) is a 6-item self-report measure assessing social engagement and perceived social support from family and friends. Total scores range from 0 to 30, with higher scores indicating larger and more supportive social networks (better outcomes). Minimum score: 0; maximum score: 30. Higher scores represent better outcomes.
Baseline, optional 4 months follow-up
Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S)
Periodo de tiempo: Baseline, optional 4 months follow-up
The HHIE-S is a 10-item self-report questionnaire assessing the emotional and social/situational effects of hearing loss in older adults. Total scores range from 0 to 40, with higher scores indicating greater perceived hearing handicap and worse hearing-related quality of life. Minimum score: 0; maximum score: 40. Higher scores represent worse outcomes.
Baseline, optional 4 months follow-up
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Periodo de tiempo: Baseline, optional 4 months follow-up
The GAD-7 is a 7-item self-report questionnaire assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity and worse outcomes. Minimum score: 0; maximum score: 21. Higher scores represent worse outcomes.
Baseline, optional 4 months follow-up
Center for Epidemiologic Studies Depression Scale (CES-D)
Periodo de tiempo: Baseline, optional 4 months follow-up
The CES-D is a 20-item self-report questionnaire assessing depressive symptoms in the general population over the past week. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity and worse outcomes. Minimum score: 0; maximum score: 60. Higher scores represent worse outcomes.
Baseline, optional 4 months follow-up
Cognitive test- MoCA
Periodo de tiempo: Baseline, optional 4-month follow-up
Montreal Cognitive Assessment (MoCA) The MoCA is a brief cognitive screening tool assessing multiple domains including memory, attention, executive function, language, visuospatial skills, and orientation. The standard MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function (better outcomes).
Baseline, optional 4-month follow-up
Duke Social Support Index (DSSI-11)
Periodo de tiempo: Baseline, optional 4-months follow-up
The DSSI-11 is an 11-item self-report measure assessing social support across social interaction and subjective support domains. Total scores range from 10 to 30, with higher scores indicating greater perceived social support (better outcomes). Minimum score: 10; maximum score: 30. Higher scores represent better outcomes.
Baseline, optional 4-months follow-up
Short Form Health Survey - 12 Item (SF-12)
Periodo de tiempo: Baseline, optional 4-months follow-up
The SF-12 is a 12-item self-report measure assessing overall health-related quality of life across physical and mental domains. Scores are typically summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. When reported as a combined or transformed total score ranging from 0 to 200, higher scores indicate better health-related quality of life (better outcomes). Minimum score: 0; maximum score: 200. Higher scores represent better outcomes.
Baseline, optional 4-months follow-up
Short Assessment of Health Literacy (SAHL)
Periodo de tiempo: Baseline, optional 4-months follow-up
The SAHL is an 18-item word recognition and comprehension test assessing health literacy. Total scores range from 0 to 18, with higher scores indicating better health literacy (better outcomes). Minimum score: 0; maximum score: 18. Higher scores represent better outcomes.
Baseline, optional 4-months follow-up
EEG Measure - Mismatch negativity amplitude
Periodo de tiempo: Baseline, optional 4-month follow-up
Mismatch Negativity (MMN) amplitude is an event-related potential (ERP) measure of automatic auditory change detection and sensory discrimination. EEG recordings will be obtained while participants complete an auditory oddball task. MMN amplitude will be quantified as the mean negative deflection (µV) elicited by deviant auditory stimuli relative to standard stimuli within the predefined MMN time window.
Baseline, optional 4-month follow-up
EEG Measure - Mismatch negativity latency
Periodo de tiempo: Baseline, optional 4-month follow-up4-month follow-up
Mismatch Negativity (MMN) latency is an event-related potential (ERP) measure of the timing of automatic auditory change detection and sensory discrimination. EEG recordings will be obtained while participants complete an auditory oddball task. MMN latency will be quantified as the time interval (milliseconds [ms]) from stimulus onset to the peak negative MMN response elicited by deviant auditory stimuli within the predefined MMN time window.
Baseline, optional 4-month follow-up4-month follow-up
EEG Measure - P300 amplitude
Periodo de tiempo: Baseline, optional 4-month follow-up
P300 amplitude is an event-related potential (ERP) measure of attentional resource allocation and cognitive processing of task-relevant stimuli. EEG recordings will be obtained while participants complete an auditory oddball task. P300 amplitude will be quantified as the peak positive deflection (microvolts [µV]) elicited by target stimuli within the predefined P300 time window following stimulus presentation.
Baseline, optional 4-month follow-up
EEG Measure - P300 latency
Periodo de tiempo: Baseline, optional 4-month follow-up
P300 latency is an event-related potential (ERP) measure of the speed of cognitive processing and stimulus evaluation. EEG recordings will be obtained while participants complete an auditory oddball task. P300 latency will be quantified as the time interval (milliseconds [ms]) from stimulus onset to the peak positive P300 response elicited by target stimuli within the predefined P300 time window.
Baseline, optional 4-month follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Southern California

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)

1 de julio de 2027

Finalización primaria (Estimado)

31 de diciembre de 2029

Finalización del estudio (Estimado)

31 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

6 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

13 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

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

  • APP-26-02104

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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