Cochlear Implantation and Social Outcomes
Trial statusNot yet recruiting
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 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cochlear implant
Procedure/SurgeryParticipants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Adults with bilateral hearing loss (cochlear implant users or candidates)1 intervention
Trial outcomes
Primary outcomes
1
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, optional 4-month follow-up2
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, optional 4-month follow-upSecondary outcomes
1
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, optional 4-month follow-up2
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-up3
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-up4
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.
Time frame
Baseline, optional 4-months follow-upSponsors and contacts
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Source ClinicalTrials.gov
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