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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04521166
Other study ID # STU00210459
Secondary ID K01DC018324
Status Completed
Phase N/A
First received
Last updated
Start date May 6, 2021
Est. completion date June 29, 2023

Study information

Verified date October 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). We anticipate the outcomes of this study to be applicable to realistic listening conditions.


Description:

Hearing aids have specialized features to improve access to sounds for the hearing-impaired listener. The choice of appropriate hearing aid settings is integral to the hearing rehabilitative process. Researchers and clinicians have been influenced by previous work showing that individual cognitive abilities, including working memory, are associated with hearing aid benefit, especially in adverse listening conditions. However, previous research is limited to omnidirectional microphone settings and unrealistic listening conditions. Such conditions fail to recognize that most hearing aids are fit with directional processing that may improve the listening environment, and that typical environments contain speech and noise signals in a range of spatial locations. Therefore, the broad goal of this research is to understand how patient variables interact with hearing aid signal processing in realistic listening conditions in order to effectively treat hearing-impaired individuals in communications situations that are most important to them.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date June 29, 2023
Est. primary completion date June 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > =18 years of age; any sex - Sensorineural hearing loss with pure-tone thresholds between 25-70 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz - Speak English as their primary language - Normal or corrected-to-normal vision (<=20/50) - Participants will be in good health (self-report) Exclusion Criteria: - Clinically significant unstable or progressive medical conditions - Participants who score < 23 on the cognitive screening test (Montreal Cognitive Assessment) - Evidence of conductive hearing loss or middle ear issues - Significant history of otologic or neurologic disorders - Evidence of significant asymmetry between ears - Non-English-speaking or non-native English speaking

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hearing aid
Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Locations

Country Name City State
United States Northwestern University Evanston Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speech intelligibility (percent correct scores) Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit. 1 day
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