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HEARS-NPS: Addressing Hearing Loss in Alzheimer's and Dementia

This study, called HEARS-NPS, is looking at a new way to help older adults (ages 60-100) with Alzheimer's Disease or other related dementias who also have hearing loss. It tests a device called the HEARS-NPS device, which is a personal sound amplifier fitted specifically for you, along with a HEARS-NPS program, which is special hearing rehabilitation for you and your care partner. The goal is to see if these interventions can reduce distress, which is measured using a tool called the Neuropsychiatric Inventory (NPI-Q). We don't know the current recruitment status, but the study plans to enroll 300 participants.

Study design
This is a randomized controlled trial, meaning participants are assigned by chance to different groups. It plans to enroll 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your distress will be measured at baseline, 6 weeks, 3 months, and 6 months after the intervention or baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06930560

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

Recruiting
NAAges 60+Interventional
Johns Hopkins University
~300 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:HEARS-NPS deviceHEARS-NPS program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)
Measured over Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)

Conditions

Alzheimer Disease
Dementia
Hearing Loss
Cognitive Impairment

Explore related trials

Alzheimer's DiseaseCognitive DysfunctionDementiaHearing Loss

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Esther Oh, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Esther Oh, MD, Ph.D.
[email protected]
410-550-0925
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)

    Scoring: Each of the 12 NPI-Q domains contains a survey question that reflects symptoms of that domain. Initial responses to each domain question are "Yes" or "No". If the response to the question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. Total NPI-Q severity score is the sum of individual symptom scores, ranges from 0 to 36. Higher score is worse SEVERITY of the symptom (how it affects the patient): 1. = Mild (noticeable, but not a significant change) 2. = Moderate (significant, but not a dramatic change) 3. = Severe