Mechanism Underlying the Link Between Hearing Loss and Cognition

Not yet recruiting

• Conditions: Hearing Loss, Bilateral (Causes Other Than Tumors)

• Registration Number: NCT06781749
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Start: 2025-04-01
• Primary Completion: 2028-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive test- MoCA	Baseline and 4-month after hearing aid use	MoCA (MoCA-Basic if appropriate) score

Secondary Outcome Measures

Name	Time	Method
Cognitive Test- Digit Span Test	Baseline, 4-month after hearing aid use	Cognitive Test- Digit Span Test
Audio sensor- speech arousal	Baseline, 4-month after hearing aid use	The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech arousal measures include the percentage of strong arousals, serving as a proxy of enhanced engagement in conversations.
Auditory oddball task	Baseline and 4-mo after hearing aid use	Auditory oddball task discrimination sensitivity
Audio sensor- speech activity	Baseline and 4-month after hearing aid use	The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech activity measures include the intersession time (the interval between speech sessions, representing the frequency of conversation engagement).
EEG Measures	Baseline, 4-month after hearing aid use	EEG Event Related Potentials (ERPs) are measures of cortical activities in response to auditory stimuli and provide information about cognitive processing, memory, and attention. Participants will complete auditory oddball tasks during EEG measurements and ERPs including P1, N1, P2, MMN, P3 will be recorded.

Trial Locations

Locations (2)

Los Angeles General Medical Center; 🇺🇸 Los Angeles, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States