Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT06068933
Eligibility Criteria:
PARTICIPANT INCLUSION CRITERIA FOR PHASE 2A: MCI-Pilot Trial
* Age ≥ 60 years
* Self-identified as first-generation Korean American
* Self-reported ability to read and speak Korean
* Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz \> 25 decibel hearing loss in better hearing ear
* Mild cognitive impairment (CDR=0.5 and/or Korean Montreal Cognitive Assessment (MoCA-K) \<23)
* Report not currently using a hearing aid
* Has a care partner able to participate in the study
* Stable medication regimen. Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms
PARTICIPANT INCLUSION CRITERIA FOR PHASE 2B: KA Older Adult-focused Trial:
* Age ≥ 60 years
* Self-identified as first-generation Korean American
* Self-reported ability to read and speak Korean
* Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz \>= 35 decibel Hearing Loss in better hearing ear
* Report not currently using a hearing aid
* Has a care partner able to participate in the study
CARE PARTNER INCLUSION CRITERIA (same for both Phase 2A and 2B)
* Age 18 years or older
* Able to read and speak Korean
* Lives in the same household with the participant or has at least daily interactions
* Aural-oral verbal communication as primary communication modality
* Able to accompany participant to all study visits
EXCLUSION CRITERIA (same for both Phase 2A and 2B)
Participant exclusion criteria
* Residence in an assisted living facility (ALF) or nursing home (NH)
* Medical contraindication to use of amplification device (e.g., draining ear)
* Currently using a hearing aid or listening device
Care partner exclusion criteria
• Individuals who do not fulfill inclusion criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
100 Years
Study:
NCT06068933
Study Brief:
Protocol Section:
NCT06068933