OTC Hearing Aid and MCI

Mild Cognitive Impairment Clinical Trial

Official title:

Over-the-counter Hearing Aids and Mild Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112860
• Other study ID #: STU00219514
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: Kendra Marks
• Phone: 8474670897
• Email: kendra.marks[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Hearing Loss
• Mild Cognitive Impairment

Intervention

Device:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Communication partner-reported communication ability (PCI-DAT).	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)	Baseline at enrollment, then after 4 weeks of using each intervention
Secondary	Diapix	A conversation task where participant and communication partner find the differences in two very similar pictures by discussing them.	4 weeks after first intervention
Secondary	Hearing Handicap Inventory for the Elderly (HHIE)	Questionnaire has 25 items with subscales for social and emotional impacts and is scored from 0-100, with 100 representing least handicap.	Baseline at enrollment, then after 4 weeks of using each intervention