Clinical trial NCT06112860: OTC Hearing Aid and MCI
Official title: Over-the-counter Hearing Aids and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Mild Cognitive Impairment
Alzheimer Disease and Related Dementias (ADRD)
Keywords: Over-the-counter Hearing Aids
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)
timeFrame: Baseline at enrollment, then after 4 weeks of using each intervention
Secondary outcomes:
measure: Hearing Handicap Inventory for the Elderly (HHIE)
timeFrame: Baseline at enrollment, then after 4 weeks of using each intervention
Other outcomes:
measure: Conversation Analysis
timeFrame: 4 weeks after first intervention
measure: Adherence
timeFrame: 4 weeks after each intervention
measure: Usability
timeFrame: 4 weeks after OTC intervention
Locations:
city: Evanston
country: United States
facility: Northwestern University HA Lab
state: Illinois
city: La Crosse
country: United States
facility: La Crosse Mayo Clinic
state: Wisconsin
city: Madison
country: United States
facility: UW Madison
state: Wisconsin
Study officials:
affiliation: Northwestern University
name: Pamela Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References: