Over-the-counter Hearing Aids and Mild Cognitive Impairment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Northwestern University
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)
Study Overview
Brief Summary
The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids:
- improve communication
- Whether the magnitude of benefit depends on the patient's level of cognitive disability,
- 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.
Detailed Description
This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and MCI and a communication partner. Due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Those listening and scoring recorded tasks will be blinded to which group the participants are in.
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Over 60 years of age
- •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
- •Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study.
- •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
- •Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
- •Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
- •History or current fluctuating hearing loss
Arms & Interventions
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.
Intervention: Communication Strategies Information/Counseling (Behavioral)
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.
Intervention: Communication Strategies Information/Counseling (Behavioral)
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.
Intervention: Over the counter hearing aid (Device)
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.
Intervention: Over the counter hearing aid (Device)
Outcomes
Primary Outcomes
Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)
Time Frame: Baseline at enrollment, then after 4 weeks of using each intervention
A questionnaire completed by the communication partner of the individual with MCI and hearing loss. On this scale, higher scores reflect more frequent and more problematic conversation difficulties; item possible scores range from 0 (not problematic) to 7 (.very problematic)
Secondary Outcomes
- Hearing Handicap Inventory for the Elderly (HHIE)(Baseline at enrollment, then after 4 weeks of using each intervention)
Investigators
Pamela Souza
Professor, Otolaryngology; Communication Sciences and Disorders
Northwestern University