Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT04240561

Conditions

Hearing Loss, Sensorineural

Dementia of Alzheimer Type

Amnestic Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

High level of signal manipulation

Low level of signal manipulation

Study Details

Brief summary:

This current translational project, funded by NIH, aims to better understand the impact of various signal modification strategies for older adults with Alzheimer's dementia and its potential precursor, known as amnestic mild cognitive impairment. The investigators hypothesize that adults with Alzheimer's dementia represent an extreme case of restricted cognitive ability, such that very low working memory capacity and overall reduced cognitive capacity will limit benefit from advanced signal processing. Thus, the investigators hypothesize that adults with Alzheimer's dementia will receive greater benefit from acoustically simple, high-fidelity hearing aid processing that minimally alters the acoustic signal.

Conditions

Hearing Loss, Sensorineural

Dementia of Alzheimer Type

Amnestic Mild Cognitive Impairment

Study ID

NCT04240561

Start date

Jul 1, 2021

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hearing Aid Fitting Order A

Participants wear hearing aids with a high level of signal manipulation, followed by a low level of signal manipulation

experimental: Hearing Aid Fitting Order B

Participants wear hearing aids with a low level of signal manipulation, followed by a high level of signal manipulation

Interventions

High level of signal manipulation

Hearing aid will be programmed to a high level of signal manipulation.

Low level of signal manipulation

Hearing aid will be programmed to a low level of signal manipulation.

Primary outcome measure

  • Change In Speech Intelligibility (%Correct) [ Time Frame: Change from Baseline to final appointment ineach hearing aid condition will be assessed. Participants will take an unaided baseline at the start of the trial. Measure will be repeated at the end of each intervention (3-5 weeks after each fitting). ]
  • Change in Conversation Analysis of Communication Breakdown [ Time Frame: Change from Baseline to final appointment in each hearing aid condition will be assessed. Participants will take an unaided baseline at the start of the trial. Measure will be repeated at the end of each intervention (3-5 weeks after each fitting). ]

Central Contacts and Locations

Central contacts

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

More Information

Sponsor

Northwestern University

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • mild cognitive impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-04-30.