OTC Hearing Aid and MCI

Not Applicable

Recruiting

• Conditions: Hearing Loss; Mild Cognitive Impairment; Alzheimer Disease and Related Dementias (ADRD)
• Interventions: Device: Over the counter hearing aid; Behavioral: Communication Strategies Information/Counseling

• Registration Number: NCT06112860
• Lead Sponsor: Northwestern University

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:

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.

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 Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-11-02
• Study Start: 2024-07-23
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

1. 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.
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OTC Hearing Aid First	Communication Strategies Information/Counseling	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.
Communication Strategies First	Over the counter hearing aid	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.
OTC Hearing Aid First	Over the counter hearing aid	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.
Communication Strategies First	Communication Strategies Information/Counseling	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.

Primary Outcome Measures

Name	Time	Method
Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)	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 Outcome Measures

Name	Time	Method
Hearing Handicap Inventory for the Elderly (HHIE)	Baseline at enrollment, then after 4 weeks of using each intervention	Questionnaire has 25 items with subscales for social and emotional impacts and is scored from 0-100, with 100 representing least handicap.

Trial Locations

Locations (3)

Northwestern University HA Lab; 🇺🇸 Evanston, Illinois, United States

La Crosse Mayo Clinic; 🇺🇸 La Crosse, Wisconsin, United States

UW Madison; 🇺🇸 Madison, Wisconsin, United States