HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HEARS-NPS device, HEARS-NPS program.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Dementia, Hearing Loss, Cognitive Impairment. Basic parameters: 60 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
HEARS Neuropsychiatric Symptoms & Hearing Loss: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Overview
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.
Interventions
- Device HEARS-NPS device
Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component. - Behavioral HEARS-NPS program
Tailored aural rehabilitation for participant and care partner.
Primary outcome measures
- Distress as assessed by the Neuropsychiatric Inventory (NPI-Q) [Time frame: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)]
Secondary outcome measures (3)
- Hearing Handicap Inventory for the Elderly (HHIE-S) [Time frame: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)]
- Relationship Quality as assessed by the Patient-Caregiver Closeness Scale (CG-CR) [Time frame: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)]
- International Outcome Inventory for Hearing Aids (IOI-HA) Survey [Time frame: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Johns Hopkins Memory and Alzheimer's Treatment Center — Baltimore
Identifiers
NCT: NCT06930560 · IRB00357244 · 5R01AG076525-02