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Procedure

Immediate treatment for Hearing Loss

N/A

Recruiting

Led By Esther Oh, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age 60 - 100 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 month post-intervention (immediate group). 1 month post-baseline (delayed group)

Awards & highlights

Study Summary

This trial aims to develop and test a hearing rehabilitation program that will be delivered by a speech-language pathologist to individuals with cognitive impairment. The program is designed to be affordable and easily accessible.

Who is the study for?

This trial is for English-speaking individuals aged 60-100 with probable Alzheimer's or related dementia, who live at home and have stable medication dosing. They must have adult-onset hearing loss and a caregiver available to assist with the study.Check my eligibility

What is being tested?

The HEARS-SLP program and device are being tested to see if they can help people with cognitive impairment by providing affordable hearing care through speech-language pathologists.See study design

What are the potential side effects?

Since this trial involves a non-invasive intervention focused on hearing health care, side effects may be minimal but could include discomfort from using the HEARS-SLP device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Alzheimer's Disease or a similar type of dementia.

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I am between 60 and 100 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 month post-intervention (immediate group). 1 month post-baseline (delayed group)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 month post-intervention (immediate group). 1 month post-baseline (delayed group)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 month post-intervention (immediate group). 1 month post-baseline (delayed group) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Immediate treatmentExperimental Treatment2 Interventions

immediate treatment

Group II: Delayed treatmentPlacebo Group2 Interventions

1 month delayed treatment

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,865 Total Patients Enrolled

8 Trials studying Hearing Loss

2,782 Patients Enrolled for Hearing Loss

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,477 Total Patients Enrolled

12 Trials studying Hearing Loss

4,855 Patients Enrolled for Hearing Loss

Esther Oh, MD, PhDPrincipal InvestigatorJohns Hopkins School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to apply for enrollment in this ongoing research study?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking individuals to participate. The initial posting of the study took place on December 15th, 2023 and it was last updated on January 4th, 2024. This particular clinical trial aims to recruit a total of 20 patients from a single designated location."

Answered by AI

What is the current number of participants being recruited for this research study?

"Indeed, the details provided on clinicaltrials.gov indicate that this investigation is presently in the recruitment phase. The trial was initially posted on December 15th, 2023 and subsequently updated on January 4th, 2024. The research team aims to enroll a total of 20 participants from a single designated site."

Answered by AI

Is the age criterion for participation in this medical study inclusive of individuals aged 60 and above?

"Applicants who fall within the age range of 60 to 100 are eligible for participation in this trial. It is worth noting that there are a total of 94 clinical trials available for patients under the age of 18, while there are 999 trials specifically targeting individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008782.

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