Hearing Loss, Bilateral Sensorineural
Conditions
Keywords
hearing loss, cochlear implant, social engagement, cognition
Brief summary
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.
Interventions
PROCEDURECochlear implant
Participants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study.
Sponsors
University of Southern California
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Audio sensor- speech arousal | 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. |
| Audio sensor- speech activity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive test- MoCA | 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). |
| UCLA Loneliness Scale | 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. |
| Lubben Social Network Scale (LSNS-6) | 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. |
| Duke Social Support Index (DSSI-11) | 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. |
| Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) | 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. |
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | 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. |
| Center for Epidemiologic Studies Depression Scale (CES-D) | 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. |
| Short Form Health Survey - 12 Item (SF-12) | 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. |
| Short Assessment of Health Literacy (SAHL) | 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. |
| EEG Measure - Mismatch negativity amplitude | 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. |
| EEG Measure - Mismatch negativity latency | 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. |
| EEG Measure - P300 amplitude | 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. |
| EEG Measure - P300 latency | 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. |
Countries
United States
Contacts
CONTACTJanet Choi, MD, MPH
Outcome results
None listed