Hearing Loss, Bilateral SensorineuralNCT07584837
Cochlear Implantation and Social Outcomes
An observational study of Hearing Loss, Bilateral Sensorineural, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Bilateral Sensorineural
- What is being tested?
- Cochlear implant
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals.
Who may be able to join
- 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.
Who cannot join
- Age <60 years
- Unable to complete questionnaires in English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Southern California
Los Angeles, California, 90033
Janet Choi, MD, MPH, 323-442-5790, janet.choi@med.usc.edu
About this study
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?
Read more
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.
- Conditions
- Hearing Loss, Bilateral Sensorineural
- Being tested
- Cochlear implant
- Keywords
- hearing loss, cochlear implant, social engagement, cognition
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantProcedure or surgery
Participants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study.
| Study group | Role | What they receive |
|---|---|---|
| Adults with bilateral hearing loss (cochlear implant users or candidates) | Participants with bilateral moderate to profound hearing loss who are candidates for cochlear implant or currently using cochlear implants Receives: Procedure: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, optional 4-month follow-up
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).
Measured: Baseline, optional 4-month follow-up
Secondary outcomes (13)
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).
Measured: Baseline, optional 4-month follow-up
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.
Measured: 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.
Measured: Baseline, optional 4 months follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, optional 4-months follow-up
EEG Measure - Mismatch negativity amplitude
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.
Measured: Baseline, optional 4-month follow-up
EEG Measure - Mismatch negativity latency
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.
Measured: Baseline, optional 4-month follow-up4-month follow-up
EEG Measure - P300 amplitude
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.
Measured: Baseline, optional 4-month follow-up
EEG Measure - P300 latency
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.
Measured: Baseline, optional 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Choi, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584837
- Sponsor's protocol ID
- APP-26-02104
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Implantation and Social Outcomes
- ClinicalTrials.gov ID
- NCT07584837
- Acronym / sponsor ID
- APP-26-02104
- Conditions
- Hearing Loss, Bilateral Sensorineural
- Keywords
- hearing loss, cochlear implant, social engagement, cognition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with bilateral hearing loss (cochlear implant users or candidates) | – | Procedure: Cochlear implantParticipants with bilateral moderate to profound hearing loss who are candidates for cochlear implant or currently using cochlear implants |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Age <60 years
- Unable to complete questionnaires in English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implantParticipants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study. | Procedure or surgery | Adults with bilateral hearing loss (cochlear implant users or candidates) |
Primary outcome
Audio sensor- speech arousal
Time frame: 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
Time frame: 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).
13 secondary outcomes
Cognitive test- MoCA
Time frame: Baseline, optional 4-month follow-up
UCLA Loneliness Scale
Time frame: Baseline, optional 4 months follow-up
Lubben Social Network Scale (LSNS-6)
Time frame: Baseline, optional 4 months follow-up
Duke Social Support Index (DSSI-11)
Time frame: Baseline, optional 4-months follow-up
Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S)
Time frame: Baseline, optional 4 months follow-up
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time frame: Baseline, optional 4 months follow-up
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, optional 4 months follow-up
Short Form Health Survey - 12 Item (SF-12)
Time frame: Baseline, optional 4-months follow-up
Short Assessment of Health Literacy (SAHL)
Time frame: Baseline, optional 4-months follow-up
EEG Measure - Mismatch negativity amplitude
Time frame: Baseline, optional 4-month follow-up
EEG Measure - Mismatch negativity latency
Time frame: Baseline, optional 4-month follow-up4-month follow-up
EEG Measure - P300 amplitude
Time frame: Baseline, optional 4-month follow-up
EEG Measure - P300 latency
Time frame: Baseline, optional 4-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Bilateral Sensorineural, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Choi, MD, MPH (323-442-5790, janet.choi@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audio sensor- speech arousal (time frame: Baseline, optional 4-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.