Hearing LossNCT06008782
HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment
A study testing HEARS-SLP device and HEARS-SLP program in people with Hearing Loss and Dementia, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Dementia, Cognitive Impairment
- What is being tested?
- HEARS-SLP device and HEARS-SLP program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 24 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HEARS-SLP: Providing Speech Language Pathologist-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.
- Conditions
- Hearing Loss, Dementia, Cognitive Impairment
- Being tested
- HEARS-SLP device, HEARS-SLP program
- Medical subject headings
- Hearing Loss, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEARS-SLP deviceDevice
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
HEARS-SLP programBehavioural
Tailored aural rehabilitation for participant and communication partner
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment | Experimental | immediate treatment Receives: Device: HEARS-SLP device; Behavioral: HEARS-SLP program |
| Delayed treatment | Placebo comparator | 1 month delayed treatment Receives: Device: HEARS-SLP device; Behavioral: HEARS-SLP program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
- = Mild (noticeable, but not a significant change)
- = Moderate (significant, but not a dramatic change)
- = Severe
Measured: 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
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.
Measured: 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)
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.
Measured: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start15 Dec 2023
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Esther Oh, MD, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008782
- Sponsor's protocol ID
- IRB00218068
- Other IDs
- K23AG059900
- Status last verified
- Feb 2026
- First submitted
- 18 Aug 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06008782
- Acronym / sponsor ID
- IRB00218068
- Conditions
- Hearing Loss, Dementia, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment | Experimental | Device: HEARS-SLP device, Behavioral: HEARS-SLP programimmediate treatment |
| Delayed treatment | Placebo comparator | Device: HEARS-SLP device, Behavioral: HEARS-SLP program1 month delayed treatment |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEARS-SLP deviceTailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. | Device | Delayed treatment, Immediate treatment |
| HEARS-SLP programTailored aural rehabilitation for participant and communication partner | Behavioural | Delayed treatment, Immediate treatment |
Primary outcome
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): 1. = Mild (noticeable, but not a significant change) 2. = Moderate (significant, but not a dramatic change) 3. = Severe
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Oh, MD, PhD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEARS-SLP device and HEARS-SLP program in people with Hearing Loss and Dementia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.