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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:
What Participants Will Do:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implant | Procedure | Participants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Audio sensor- speech arousal | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive test- MoCA | 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 |
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Inclusion Criteria:
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Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janet Choi, MD, MPH | Contact | 323-442-5790 | janet.choi@med.usc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| UCLA Loneliness Scale | 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) | 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 |
| Duke Social Support Index (DSSI-11) | 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 |
| Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) | 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 | 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) | 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 |
| Short Form Health Survey - 12 Item (SF-12) | 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) | 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 | 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 | 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 | 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 | 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 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |