NCT06112860Recruiting
OTC Hearing Aid and MCI
Over-the-counter Hearing Aids and Mild Cognitive Impairment
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 25 Oct 2023
- Start date
- 23 Jul 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Northwestern University
- Diseases
- Alzheimer disease
- NCT number
- NCT06112860
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 23 Jul 2024 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
- History or current fluctuating hearing loss
Who the study is looking for
- 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
Age in the registry: 60 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University HA Lab Coordinator of this site? Confirm its status | Evanston | United States | Recruiting |
| La Crosse Mayo Clinic Coordinator of this site? Confirm its status | La Crosse | United States | Completed |
| UW Madison Coordinator of this site? Confirm its status | Madison | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.