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Behavioral Intervention

OTC Hearing Aid for Cognitive Impairment

N/A

Waitlist Available

Led By Pamela 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

Over 60 years of age

No vision impairment that would interfere with the ability to complete study tasks

Must not have

History or current fluctuating hearing loss

Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline at enrollment, then after 4 weeks of using each intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if Over-the-Counter (OTC) hearing aids can help improve communication in patients with mild to moderate hearing loss and mild cognitive impairment or Alzheimer's disease. The study will

Who is the study for?

This trial is for individuals over 60 with mild dementia or mild cognitive impairment and mild to moderate hearing loss who don't currently use a hearing aid. They must have a partner to communicate with during the study, be able to consent, and not have severe vision impairments.

What is being tested?

The study aims to see if Over-the-Counter (OTC) hearing aids help improve communication in patients with cognitive challenges and whether targeted communication strategies offer similar benefits. Participants will try either the OTC hearing aid or communication strategies first, then switch.

What are the potential side effects?

While specific side effects are not detailed for this trial, typical concerns may include discomfort from wearing the device, potential feedback noise from the aid, or frustration if communication isn't improved as expected.

Eligibility Criteria

Inclusion Criteria

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

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I am over 60 years old.

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My vision is good enough to do study tasks.

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I am capable of understanding and giving my consent for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My hearing loss comes and goes.

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I have a history of a major psychiatric disorder like schizophrenia or severe depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline at enrollment, then after 4 weeks of using each intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline at enrollment, then after 4 weeks of using each intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline at enrollment, then after 4 weeks of using each intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)

Secondary study objectives

Hearing Handicap Inventory for the Elderly (HHIE)

Other study objectives

Adherence

Conversation Analysis

Usability

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: OTC Hearing Aid FirstExperimental Treatment2 Interventions

Participants will be provided a pair of OTC hearing aids (experimental) with typical directions and use for 4 weeks before outcome measures will be assessed. After which, participants will then receive the communication strategies information/counseling (control) and have outcome measures assessed after 4 weeks.

Group II: Communication Strategies FirstExperimental Treatment2 Interventions

Participants will receive the communication strategies information/counseling intervention (control) first. Outcome measures will be assessed at 4 weeks. After which, participants will then be given a pair of OTC hearing aids (experimental) with typical directions and use for four weeks before having outcome measures assessed.

0 / 5Eligibility criteria met