Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-07-23
2026-12-31
Brief Summary
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1. improve communication
2. Whether the magnitude of benefit depends on the patient's level of cognitive disability,
3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits.
Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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OTC Hearing Aid First
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.
Over the counter hearing aid
An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.
Communication Strategies Information/Counseling
Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.
Communication Strategies First
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.
Over the counter hearing aid
An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.
Communication Strategies Information/Counseling
Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.
Interventions
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Over the counter hearing aid
An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.
Communication Strategies Information/Counseling
Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
* Mild to moderate bilateral hearing loss and no current hearing aid use.
* A communication partner who is able and willing to participate in the study.
* No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
* Able to provide own consent as evaluated by the Consent Assessment
Exclusion Criteria
2. History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
3. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
5. History or current fluctuating hearing loss
60 Years
90 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Pamela Souza
Professor, Otolaryngology; Communication Sciences and Disorders
Principal Investigators
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Pamela Souza, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University HA Lab
Evanston, Illinois, United States
La Crosse Mayo Clinic
La Crosse, Wisconsin, United States
UW Madison
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00219514
Identifier Type: -
Identifier Source: org_study_id
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