RECRUITING

OTC Hearing Aid and MCI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Over-the-counter Hearing Aids and Mild Cognitive Impairment

Quick Facts

Study Start:2024-07-23
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06112860

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Over 60 years of age
  2. * Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
  3. * Mild to moderate bilateral hearing loss and no current hearing aid use.
  4. * A communication partner who is able and willing to participate in the study.
  5. * No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
  6. * Able to provide own consent as evaluated by the Consent Assessment
  1. 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. 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. 3. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
  4. 4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
  5. 5. History or current fluctuating hearing loss

Contacts and Locations

Study Contact

Kendra Marks
CONTACT
8474670897
kendra.marks@northwestern.edu

Principal Investigator

Pamela Souza, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University HA Lab
Evanston, Illinois, 60201
United States
La Crosse Mayo Clinic
La Crosse, Wisconsin, 54601
United States
UW Madison
Madison, Wisconsin, 53706
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Pamela Souza, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-23
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-07-23
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Over-the-counter Hearing Aids

Additional Relevant MeSH Terms

  • Hearing Loss
  • Mild Cognitive Impairment
  • Alzheimer Disease and Related Dementias (ADRD)