RightFit
RecruitingNot applicable

OTC Hearing Aid and MCI

Over-the-counter Hearing Aids and Mild Cognitive Impairment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether hearing aids sold without a prescription improve communication for adults over 60 with mild to moderate hearing loss and mild memory or thinking problems or mild dementia. It also looks at whether the level of thinking problems affects the benefit and whether communication tips help as much. Participants and a communication partner are assigned by chance to try hearing aids or communication tips first.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are over 60 years old.
  • You have mild dementia or mild cognitive impairment (mild memory or thinking problems), diagnosed at a participating memory center.
  • You have mild to moderate hearing loss in both ears and do not currently use hearing aids.
  • You have a communication partner who is willing and able to take part.
  • You do not have vision problems that would keep you from completing study tasks.
  • You can give your own consent to join, based on a study assessment.

Who can't join

  • You have a serious medical condition that is unstable or getting worse, or a condition the study team believes makes joining too risky.
  • You have ongoing communication problems after another brain or nerve condition, such as a stroke or brain tumor; a developmental condition, such as Down syndrome; or head or neck cancer.
  • You have a history of a major mental health condition, such as schizophrenia or serious untreated depression.
  • You are also in another study testing treatments for hearing, language, or communication.
  • You have or have had hearing loss that changes over time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

IL

WI