New Approach to Objectively Measure Social Engagement in Older Adults With Hearing Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Age <60 years
Unable to complete questionnaires in English or Spanish
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hearing aid use
DeviceHearing 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Adults with bilateral hearing loss (hearing aid users)1 intervention
Group B: Adults without hearing loss0 interventions
Group C: Adults with hearing loss (non-hearing aid users)0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline and 4-month after hearing aid use2
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.
Time frame
Baseline, 4-month after hearing aid useSecondary outcomes
1
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.
Time frame
Baseline, 4-month after hearing aid use2
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).
Time frame
Baseline and 4-month after hearing aid use3
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.
Time frame
Baseline, optional 4 months follow-up4
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.
Time frame
Baseline, optional 4 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov