HEARS-NPS for Alzheimer's Disease

(HEARS-NPS Trial)

Overseen By Jami Trumbo, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Hearing aid use, Draining ears, others

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hearing care program, the HEARS-NPS program, for individuals with Alzheimer's Disease or similar types of dementia. The goal is to determine if improved hearing can enhance communication and reduce distressing symptoms for both those with dementia and their caregivers. Participants will either begin the program immediately or after a short delay to compare results. Ideal participants have Alzheimer's, some level of hearing loss, and a caregiver who can accompany them to study visits. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for those with dementia and their caregivers.

What prior data suggests that the HEARS-NPS device and program are safe for older adults with Alzheimer's Disease?

Research has shown that hearing care programs like HEARS-NPS are designed to help individuals with Alzheimer's and similar conditions communicate better and experience fewer symptoms. Specific safety data for the HEARS-NPS program is not available, but the "Not Applicable" phase designation likely indicates the use of non-invasive methods, which are generally safe.

Hearing care programs often include hearing aids or communication techniques, which are typically easy to use and carry little risk. These methods are not known to cause serious side effects. Although specific safety information for HEARS-NPS is lacking, similar programs have been used successfully without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HEARS-NPS program for Alzheimer's disease because it offers a novel approach by focusing on non-pharmacological interventions to manage neuropsychiatric symptoms. Unlike standard treatments that often rely on medications to alleviate symptoms like agitation and depression, HEARS-NPS uses structured activities, personalized to each patient, to engage them cognitively and emotionally. This approach not only aims to improve quality of life but also reduces the reliance on drugs, which can have significant side effects. By addressing symptoms through behavioral strategies, HEARS-NPS has the potential to offer a safer, more holistic alternative for individuals with Alzheimer's disease.

What evidence suggests that the HEARS-NPS program and device are effective for Alzheimer's Disease?

Studies have shown that improving hearing in older adults with Alzheimer's Disease can enhance communication and reduce symptoms like mood swings or anxiety. Better hearing may help the brain process sounds more easily. Research indicates that treating hearing loss also reduces caregiver stress. Early findings suggest that the HEARS-NPS program, tested in this trial, could play a significant role in these improvements. Participants will either receive immediate treatment with the HEARS-NPS program or join a delayed treatment group. These benefits make the HEARS-NPS program a promising option for those with Alzheimer's and hearing loss. ^{6 7 8 9 10}

Who Is on the Research Team?

Esther Oh, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 60-100 with Alzheimer's or related dementias, who have adult-onset hearing loss and speak English. They need a caregiver to join them in the study. People can't join if they're unstable on medications for neuropsychiatric symptoms.

Inclusion Criteria

I speak English.

I have a caregiver 18 or older to help me with my study visits.

I have adult-onset hearing loss with a specific level of hearing reduction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a community-delivered hearing care intervention to assess impact on communication, neuropsychiatric symptoms, and care partner distress

6 weeks

Baseline, 6-week, 3-month, and 6-months post-intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3-month and 6-months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• HEARS-NPS device
• HEARS-NPS program

Trial Overview The HEARS-NPS device and program are being tested to see if they help older adults with dementia communicate better, reduce distressing mental health symptoms, and ease caregiver stress through community-delivered hearing care.

How Is the Trial Designed?

Group I: Immediate treatment Experimental Treatment 2 Interventions

Group II: Delayed treatment Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06930560

Study Details | NCT06930560 | HEARS-NPS: Addressing ... This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias ( ...

2. ctv.veeva.com ctv.veeva.com/study/hears-nps-addressing-hearing-loss-as-a-common-unmet-contributor-of-neuropsychiatric-symptoms

HEARS-NPS: Addressing Hearing Loss as a Common Unmet ... This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and ...

3. geiselmed.dartmouth.edu geiselmed.dartmouth.edu/news/2025/new-dartmouth-led-study-seeks-to-determine-whether-hearing-loss-speeds-the-progression-of-alzheimers-disease/

New Dartmouth-led Study Seeks to Determine Whether ... “We hope the results will show the role that both the ear and the brain play in hearing loss associated with Alzheimer's disease,” says Buckey.

4. reporter.nih.gov reporter.nih.gov/search/h9Gn1asAHkSO0O1HTCas_A/project-details/10740008

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

5. app.trialscreen.org app.trialscreen.org/trials/hears-nps-addressing-hearing-loss-common-unmet-contributor-neuropsychiatric-trial-nct06930560

Addressing Hearing Loss as a Common Unmet Contributor ... Benefits: Participation may help improve communication, reduce neuropsychiatric symptoms, and decrease caregiver distress for those with ADRD and hearing loss.

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/592823

HEARS-NPS: Addressing Hearing Loss as a Common Unmet ... This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias ...

7. nia.nih.gov nia.nih.gov/about/2025-nih-dementia-research-progress-report

2025 NIH Alzheimer's Disease and Related Dementias ... When combined with health care utilization data, the programs were approximately 86% accurate in predicting an Alzheimer's diagnosis seven ...

8. alz.org alz.org/getmedia/ef8f48f9-ad36-48ea-87f9-b74034635c1e/alzheimers-facts-and-figures.pdf

2025 Alzheimer's Disease Facts and Figures 2025 Alzheimer's Disease Facts and Figures is a statistical resource for U.S. data related to Alzheimer's disease, the.

9. aspe.hhs.gov aspe.hhs.gov/national-plan-address-alzheimers-disease

National Plan to Address Alzheimer's Disease Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025. Goal 2: Enhance Care Quality and Efficiency. Goal 3: Expand Supports for People with ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05173922

"Safety in Dementia": An Online Caregiver Intervention In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of ...