Cochlear Implantation and Social Outcomes

May 6, 2026 updated by: Janet Choi, University of Southern California

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age <60 years
  • Unable to complete questionnaires in English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: Cochlear implant
Participants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, optional 4-month follow-up
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).
Baseline, optional 4-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UCLA Loneliness Scale
Time Frame: Baseline, optional 4 months follow-up
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)
Time Frame: Baseline, optional 4 months follow-up
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
Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S)
Time Frame: Baseline, optional 4 months follow-up
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
Time Frame: Baseline, optional 4 months follow-up
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)
Time Frame: Baseline, optional 4 months follow-up
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
Cognitive test- MoCA
Time Frame: Baseline, optional 4-month follow-up
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, optional 4-month follow-up
EEG Measures
Time Frame: Baseline, optional 4-month follow-up
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, optional 4-month follow-up
Duke Social Support Index (DSSI-11)
Time Frame: Baseline, optional 4-months follow-up
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.
Baseline, optional 4-months follow-up
Short Form Health Survey - 12 Item (SF-12)
Time Frame: Baseline, optional 4-months follow-up
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)
Time Frame: Baseline, optional 4-months follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP-26-02104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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