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Signal Processing Strategy

Hearing Aid Signal Processing for Alzheimer's Disease

N/A
Recruiting
Led By Pam Souza, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal or corrected to normal vision (20/40 binocular vision or unaided using a Snellen chart)
Sensorineural hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 500 and 3000 Hz and a 4 frequency (.5, 1, 2, 3 kHz) pure-tone average of greater than or equal to 30 dB in each ear
Must not have
Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to final appointment in each hearing aid condition will be assessed. participants will take an unaided baseline at the start of the trial. measure will be repeated at the end of each intervention (3-5 weeks after each fitting).
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing different signal processing strategies for hearing aids to see which one works better for people with Alzheimer's dementia.

Who is the study for?
This trial is for older adults with Alzheimer's dementia or its precursor, amnestic mild cognitive impairment. Participants must speak English, have normal vision or corrected-to-normal vision, sensorineural hearing loss within specific parameters, and a certain level of cognitive function. They should live at home and be able to consent to the study.
What is being tested?
The study tests two types of signal manipulation in hearing aids: one with high levels of alteration and another with low levels. It aims to determine which strategy benefits those with Alzheimer's dementia more by providing clearer sound without too much processing.
What are the potential side effects?
Since this trial involves non-invasive interventions related to hearing aid technology, side effects are minimal but may include discomfort from wearing the devices or challenges adapting to new auditory experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vision is normal or corrected to normal (20/40).
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I have moderate hearing loss in both ears.
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I have been diagnosed with Alzheimer's or mild memory loss with a MoCA score of at least 18.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have hearing loss that is present from birth or changes in severity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to final appointment ineach hearing aid condition will be assessed. participants will take an unaided baseline at the start of the trial. measure will be repeated at the end of each intervention (3-5 weeks after each fitting).
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to final appointment ineach hearing aid condition will be assessed. participants will take an unaided baseline at the start of the trial. measure will be repeated at the end of each intervention (3-5 weeks after each fitting). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change In Speech Intelligibility (%Correct)
Change in Conversation Analysis of Communication Breakdown

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Hearing Aid Fitting Order BExperimental Treatment2 Interventions
Participants wear hearing aids with a low level of signal manipulation, followed by a high level of signal manipulation
Group II: Hearing Aid Fitting Order AExperimental Treatment2 Interventions
Participants wear hearing aids with a high level of signal manipulation, followed by a low level of signal manipulation

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,495 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
182,038 Total Patients Enrolled
Pam Souza, PhDPrincipal InvestigatorNorthwestern University

Media Library

Alzheimer's Dementia Research Study Groups: Hearing Aid Fitting Order A, Hearing Aid Fitting Order B
Alzheimer's Dementia Clinical Trial 2023: High level of signal manipulation Highlights & Side Effects. Trial Name: NCT04240561 — N/A
~2 spots leftby Apr 2025