Cochlear Implantation and Social Outcomes

NCT07584837 | Not Yet Recruiting

• 1 other identifier: APP-26-02104
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hearing Loss, Bilateral Sensorineural

Keywords

hearing loss; cochlear implant; social engagement; cognition

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Baseline, optional 4-month follow-up

Secondary Outcomes (10)

• Cognitive test- MoCA

  Baseline, optional 4-month follow-up

• UCLA Loneliness Scale

  Baseline, optional 4 months follow-up

• EEG Measures

  Baseline, optional 4-month follow-up

• Lubben Social Network Scale (LSNS-6)

  Baseline, optional 4 months follow-up

• Duke Social Support Index (DSSI-11)

  Baseline, optional 4-months follow-up

Study Arms (1)

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

Interventions

Cochlear implant PROCEDURE

Participants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study.

Adults with bilateral hearing loss (cochlear implant users or candidates)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Central Study Contacts

Janet Choi, MD, MPH

CONTACT

323-442-5790; janet.choi@med.usc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)