New Approach to Objectively Measure Social Engagement in Older Adults With Hearing Loss

Study Purpose

The goal of this clinical trial is to learn if hearing devices, like hearing aids and 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 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 60 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age >= 60 years.
  • - English or Spanish speaking.
  • - Individuals who were diagnosed with bilateral hearing loss or healthy volunteers without hearing loss.

Exclusion Criteria:

  • - Age <60 years.
- Unable to understand English or Spanish

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06781749
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Southern California
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hearing Loss, Bilateral (Causes Other Than Tumors)
Arms & Interventions

Arms

: Adults with bilateral hearing loss

Hearing loss defined as speech-frequency pure-tone average >=25 dB HL bilaterally

: Adults without hearing loss

Hearing loss defined as speech-frequency pure-tone average >=25 dB HL bilaterally

Interventions

Device: - Hearing aid use

Hearing aid use will be discussed with all eligible participants with hearing loss and will be encouraged to pursue hearing aid fitting through standard clinical indications via participants' insurance and audiologists.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles General Medical Center, Los Angeles 5368361, California 5332921

Status

Address

Los Angeles General Medical Center

Los Angeles 5368361, California 5332921, 90033

Site Contact

Janet Choi, MD, MPH

[email protected]

323-442-5790

University of Southern California, Los Angeles 5368361, California 5332921

Status

Address

University of Southern California

Los Angeles 5368361, California 5332921, 90066

Site Contact

Janet Choi, MD, MPH

[email protected]

323-442-5790

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