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Clinical Trials/NCT07584837
NCT07584837Not yet recruitingNot Applicable

Cochlear Implantation and Social Outcomes

University of Southern California1 site in 1 country40 target enrollmentStarted: July 1, 2027Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
1

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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

Intervention: Cochlear implant (Procedure)

Outcomes

Primary Outcomes

Not specified

Secondary Outcomes

  • EEG Measure - Mismatch negativity amplitude(Baseline, optional 4-month follow-up)
  • EEG Measure - Mismatch negativity latency(Baseline, optional 4-month follow-up4-month follow-up)
  • EEG Measure - P300 amplitude(Baseline, optional 4-month follow-up)
  • EEG Measure - P300 latency(Baseline, optional 4-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Janet Choi

Principal Investigator

University of Southern California

Study Sites (1)

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