New Approach to Objectively Measure Social Engagement in Older Adults With Hearing Loss
1 other identifier
observational
100
1 country
2
Brief Summary
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2026
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
January 13, 2026
January 1, 2026
1.5 years
January 8, 2025
January 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive test- MoCA
MoCA (MoCA-Basic if appropriate) score
Baseline and 4-month after hearing aid use
Secondary Outcomes (5)
Cognitive Test- Digit Span Test
Baseline, 4-month after hearing aid use
Audio sensor- speech arousal
Baseline, 4-month after hearing aid use
Audio sensor- speech activity
Baseline and 4-month after hearing aid use
EEG Measures
Baseline, 4-month after hearing aid use
Auditory oddball task
Baseline and 4-mo after hearing aid use
Study Arms (3)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Age \>= 60 years
- English or Spanish speaking
- Group 1- older adults with normal hearing defined as speech frequency PTA \<25dB HL in bilateral ears
- Group 2- older adults with bilateral hearing loss who are not using hearing aids
- Group 3- older adults with bilateral hearing loss, who are currently using hearing aids
You may not qualify if:
- Age \<60 years
- Unable to complete questionnaires in English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
University of Southern California
Los Angeles, California, 90066, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 8, 2025
First Posted
January 17, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2030
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share