Hearing Aid Processing and Working Memory in Realistic Spatial Conditions (DIRWDRCWM)

October 3, 2023 updated by: Varsha Rallapalli, Northwestern University

Investigating the Relationship Between Directional Microphones, Compression, and Working Memory in Realistic Spatial Conditions.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Setting 1
Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression
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.
Experimental: Setting 2
Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression
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.
Experimental: Setting 3
Hearing aid features presented in this arm include directional microphone settings and fast-acting compression
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.
Experimental: Setting 4
Hearing aid features presented in this arm include directional microphone settings and slow-acting compression
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech intelligibility (percent correct scores)
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Varsha Rallapalli, AuD, PhD, 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 Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Actual)

June 29, 2023

Study Completion (Actual)

June 29, 2023

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00210459
  • K01DC018324 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss, Sensorineural

Clinical Trials on Hearing aid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe