Clinical trial NCT06781749: Mechanism Underlying the Link Between Hearing Loss and Cognition
Official title: Mechanism Underlying the Link Between Hearing Loss and Cognition
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hearing Loss, Bilateral (Causes Other Than Tumors)
Keywords: hearing loss
hearing aids
cognition
dementia
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals and hearing aid centers. Both individuals with audiometry-measured bilateral hearing loss who are clinically indicated for hearing aid fitting and healthy volunteers without hearing loss will be recruited to participant in the study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age \>= 50 years
* English or Spanish speaking
* Individuals who were diagnosed with bilateral hearing loss or healthy volunteers without hearing loss

Exclusion Criteria:

* Age \<50 years
* Unable to understand English or Spanish

Primary outcomes:
measure: Cognitive test- MoCA
timeFrame: Baseline and 4-month after hearing aid use
Secondary outcomes:
measure: Cognitive Test- Digit Span Test
timeFrame: Baseline, 4-month after hearing aid use
measure: Audio sensor- speech arousal
timeFrame: Baseline, 4-month after hearing aid use
measure: Audio sensor- speech activity
timeFrame: Baseline and 4-month after hearing aid use
measure: EEG Measures
timeFrame: Baseline, 4-month after hearing aid use
measure: Auditory oddball task
timeFrame: Baseline and 4-mo after hearing aid use
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: