Recruiting

OTC Hearing Aid

Sponsor:

Northwestern University

Code:

NCT06112860

Conditions

Hearing Loss

Mild Cognitive Impairment

Alzheimer Disease and Related Dementias (ADRD)

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Over the counter hearing aid

Communication Strategies Information/Counseling

Study Details

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.

Conditions

Hearing Loss

Mild Cognitive Impairment

Alzheimer Disease and Related Dementias (ADRD)

Study ID

NCT06112860

Start date

Jul 23, 2024

Status verified date

Sep, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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.

other: 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.

Interventions

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.

Primary outcome measure

  • Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT) [ Time Frame: Baseline at enrollment, then after 4 weeks of using each intervention ]

Central Contacts and Locations

Central contacts

Locations

Northwestern University HA Lab

Recruiting

Evanston, Illinois, United States, 60201

Contacts

More Information

Sponsor

Northwestern University

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Over-the-counter Hearing Aids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-09-04.