PROJECT SUMMARY
As the number of adults age 65 and older continue to increase, the prevalence of Alzheimer’s disease and
other related dementias (ADRD) is also expected to increase in the U.S. Neuropsychiatric symptoms (NPS)
such as agitation, apathy, depression, and sleep disturbance are highly prevalent in patients with ADRD, with
up to 97% of the individuals suffering at least one NPS over the disease course. NPS requires considerable
management and time by care partners, and are associated with rapid cognitive and functional decline, worse
quality of life, greater care partner burden, and earlier nursing home admissions. Although nonpharmacological
intervention for NPS is recommended, psychotropic medications continue to be widely prescribed, resulting in
adverse events. Similar to ADRD, the prevalence of hearing loss increases with age. However, hearing care as
tertiary prevention for older adults who have already developed cognitive impairment has largely been ignored.
MPIs and the Co-Is of the current proposal have been working together for many years, demonstrating that i)
there is a high prevalence of hearing loss among indiviudals with mild cognitive impairment (MCI) and ADRD,
ii) increasing severity of hearing loss is associated with greater number of NPS and NPS severity, and that iii) a
user-centered hearing care intervention that utilizes emerging over-the-counter (OTC) hearing technology may
ameliorate NPS. The current proposal is based upon a prior NIA Stage 1b trial that involved an initial pilot
study of a hearing care intervention that utilized OTC hearing devices and was delivered in an outpatient
setting. The proposed study returns to Stage 1a and 1b to refine and test the preliminary efficacy of a revised
hearing care intervention strategy that targets NPS and examines the underlying mechanism(s) of action. Aim
1 seeks to refine the hearing care intervention through a Stage 1a study that involves consultation with experts
and end-users to develop a revised intervention protocol that integrates the latest evidence-informed
approaches to NPS along with alignment with theoretical frameworks, consideration of implementation
challenges encountered in the initial pilot study, and the ability to deliver the intervention in various settings,
including the home. Aim 2 will then assess the preliminary efficacy of the revised hearing care intervention
through a larger Stage 1b randomized controlled trial, which will allow for greater rigor in assessing the
intervention than prior work. Aim 3 will employ a mixed methods approach to characterize response
heterogeneity and underlying mechanism(s) of action. The proposed study embraces the iterative and
multidirectional nature of the NIA Stage Model with the goal of developing impactful behavioral interventions
that reach the maximum level of potency and potentially implementable to the maximum number of older
adults. This proposal builds critical foundational knowledge regarding the role of hearing care as an integral
component of managing NPS. These findings will directly translate to a larger Stage 2/3 efficacy trial.