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NCT Number: NCT06008782

HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment

Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be delivered by a SLP to individuals with cognitive impairment.

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Key information

Conditions

Hearing Loss Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Ear Diseases Hearing Disorders Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Medicine

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 60 - 100 years old
  • English-speaking
  • Lives at home
  • 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
  • Availability of caregiver/study partner to participate in all study-related visits and who provides ≥8 hours of weekly oversight/care
  • Speech frequency pure tone average (0.5- 4 kHz) >25 db in the better-hearing ear; adult onset hearing loss
  • 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

Treatment and study plan

HEARS-SLP device

Device

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

HEARS-SLP program

Behavioral

Tailored aural rehabilitation for participant and communication partner

Primary outcomes

  1. Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)

    Time frame: Baseline and 1 month post-intervention (immediate group). 1 month 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 on them 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.

    SEVERITY of the symptom (how it affects the patient):

    • = Mild (noticeable, but not a significant change)
    • = Moderate (significant, but not a dramatic change)
    • = Severe

Secondary outcomes

  1. Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale

    Time frame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)

    Scoring for QOL-AD:

    Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.

    The total score is the sum of all 13 items. Total scores range from 13 to 52.

  2. Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)

    Time frame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)

    Higher scores indicate increased hearing handicap.

    Scoring:

    0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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