NCT06008782

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

August 18, 2023

Last Update Submit

February 25, 2026

Conditions

DementiaCognitive ImpairmentHearing Loss

Outcome Measures

Primary Outcomes (1)

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

    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): 1. = Mild (noticeable, but not a significant change) 2. = Moderate (significant, but not a dramatic change) 3. = Severe

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (2)

Immediate treatment

EXPERIMENTAL

immediate treatment

Device: HEARS-SLP deviceBehavioral: HEARS-SLP program

Delayed treatment

PLACEBO COMPARATOR

1 month delayed treatment

Device: HEARS-SLP deviceBehavioral: HEARS-SLP program

Interventions

HEARS-SLP deviceDEVICE

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

Delayed treatmentImmediate treatment
HEARS-SLP programBEHAVIORAL

Tailored aural rehabilitation for participant and communication partner

Delayed treatmentImmediate treatment

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Hearing LossDementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Esther Oh, MD, PhD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 24, 2023

Study Start

December 15, 2023

Primary Completion

February 24, 2026

Study Completion

February 24, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)