Menu
Not yet recruiting NCT07584837

Cochlear Implantation and Social Outcomes

— Observational Hearing Loss, Bilateral Sensorineural

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cochlear implant.
Who it may be relevant to
Registry conditions: Hearing Loss, Bilateral Sensorineural. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Audio sensor- speech arousal [Time frame: Baseline, optional 4-month follow-up]
  • Audio sensor- speech activity [Time frame: Baseline, optional 4-month follow-up]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Southern California — Los Angeles

Identifiers

NCT: NCT07584837 · APP-26-02104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗