HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms

Johns Hopkins University

Status: Enrolling

Conditions: Alzheimer Disease; Cognitive Impairment; Hearing Loss; Dementia

Treatments: Device: HEARS-NPS device; Behavioral: HEARS-NPS program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06930560

5R01AG076525-02 (U.S. NIH Grant/Contract)

IRB00357244

Details and patient eligibility

About

This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress.

Enrollment: 300 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 60 - 100 years old
• English-speaking
• Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines
• Speech frequency pure tone average (0.5- 4 kHz) >25 db in the better-hearing ear; adult onset hearing loss
• Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision
• Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms

Exclusion criteria

• Current self-reported use of hearing aid or amplification device
• Medical contraindication to use hearing aids ( e.g. draining ears)
• Inability to participate in the 1-month follow up

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Immediate treatment

Experimental group

Treatment:

Behavioral: HEARS-NPS program

Device: HEARS-NPS device

Delayed treatment

Placebo Comparator group

Treatment:

Behavioral: HEARS-NPS program

Device: HEARS-NPS device