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Active NON-SBIR/STTR RPGS NIH (US)

Addressing Hearing Loss as a Common Unmet Contributor to Neuropsychiatric Symptoms

$8.18M USD

Funder NATIONAL INSTITUTE ON AGING
Recipient Organization Johns Hopkins University
Country United States
Start Date Jun 15, 2022
End Date May 31, 2027
Duration 1,811 days
Number of Grantees 2
Roles Co-Investigator; Principal Investigator
Data Source NIH (US)
Grant ID 10417874
Grant Description

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.

All Grantees

Johns Hopkins University

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