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Search / Trial NCT04240561

Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia

Launched by NORTHWESTERN UNIVERSITY · Jan 21, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Mild Cognitive Impairment

ClinConnect Summary

**Clinical Trial Summary: Understanding Hearing Aid Outcomes in Older Adults with Alzheimer's Dementia**

This clinical trial is focused on understanding how different types of hearing aid technology can help older adults who have Alzheimer's dementia or mild memory issues known as amnestic mild cognitive impairment. The researchers believe that people with Alzheimer's dementia may struggle to benefit from complex hearing aid features because of their reduced ability to process sounds. Instead, they think that simpler hearing aids, which provide clear and natural sound without much alteration, might work better for these individuals.

To participate in this trial, you should primarily speak English, have some degree of hearing loss that falls within specific limits, and experience mild cognitive issues related to memory and thinking. You should also be living at home and be able to provide consent for your participation. If you join the study, you can expect to help researchers learn more about how hearing aids can be tailored to better meet the needs of older adults with these conditions. This research is important as it may lead to improved hearing solutions for those affected by Alzheimer's dementia.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Speak English as their primary language
  • 2. Normal or corrected to normal vision (20/40 binocular vision or unaided using a Snellen chart)
  • 3. Sensorineural hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 500 and 3000 Hz and a 4 frequency (.5, 1, 2, 3 kHz) pure-tone average of greater than or equal to 30 dB in each ear
  • 4. Clinical Dementia Rating (CDR) of 0.5 or 1 (indicating slight or mild cognitive impairment in the areas of memory, orientation, judgment/problem solving, community affairs, behavior at home/hobbies, and personal care)
  • 5. Diagnosis of dementia Alzheimer's type or amnestic mild cognitive impairment (minimum MoCA score of 18).
  • 6. Living at home
  • 7. Minimum Grade 10 education
  • 8. 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 (e.g. stroke or brain tumor), neurodevelopmental disorder (e.g. Down's syndrome), or head/neck cancer
  • 3. Positive history of major psychiatric disorder (e.g. schizophrenia, significant untreated depression)
  • 4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies
  • 5. Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss
  • 6. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)

About Northwestern University

Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.

Locations

Chicago, Illinois, United States

Evanston, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Pam Souza, PhD

Principal Investigator

Northwestern University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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