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The goal of this clinical trial is to learn if hearing devices, like hearing aids, 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 (hearing aid users) | Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average >=25 dB HL bilaterally) and currently using hearing aids. |
| |
| Adults without hearing loss | Hearing loss defined as speech-frequency pure-tone average >=25 dB HL bilaterally | ||
| Adults with hearing loss (non-hearing aid users) | Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average >=25 dB HL bilaterally) and not currently using hearing aids. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aid use | Device | Hearing aid use will be discussed with all eligible participants with hearing loss and will be encouraged to pursue hearing aid fitting through standard clinical indications via participants' insurance and audiologists. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 and 4-month after hearing aid use |
| 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, 4-month after hearing aid use |
| Measure | Description | Time Frame |
|---|---|---|
| EEG Measures | EEG Event Related Potentials (ERPs) are measures of cortical activities in response to auditory stimuli and provide information about cognitive processing, memory, and attention. Participants will complete auditory oddball tasks during EEG measurements and ERPs including P1, N1, P2, MMN, P3 will be recorded. | Baseline, 4-month after hearing aid use |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals and hearing aid centers. Both individuals with audiometry-measured bilateral hearing loss who are clinically indicated for hearing aid fitting and healthy volunteers without hearing loss will be recruited to participant in the study.
| 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 |
|---|---|---|---|---|---|---|
| Los Angeles General Medical Center | Recruiting | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 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 and 4-month after hearing aid use |
| 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 Duke Social Support Index (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 |
| University of Southern California | Recruiting | Los Angeles | California | 90066 | United States |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |