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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2030-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Hearing Loss, Bilateral (Causes Other Than Tumors)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults with bilateral hearing loss (hearing aid users)

Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average \>=25 dB HL bilaterally) and currently using hearing aids.

Hearing aid use

Intervention Type DEVICE

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.

Adults without hearing loss

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

No interventions assigned to this group

Adults with hearing loss (non-hearing aid users)

Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average \>=25 dB HL bilaterally) and not currently using hearing aids.

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>= 60 years
* English or Spanish speaking
* Group 1- older adults with normal hearing defined as speech frequency PTA \<25dB HL in bilateral ears
* Group 2- older adults with bilateral hearing loss who are not using hearing aids
* Group 3- older adults with bilateral hearing loss, who are currently using hearing aids