Hearing Aid Processing and Working Memory in Realistic Spatial Conditions (DIRWDRCWM)
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing aid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring hearing aids, directional microphones, cognition, compression
Eligibility Criteria
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
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Setting 1
Setting 2
Setting 3
Setting 4
Arm Description
Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression
Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression
Hearing aid features presented in this arm include directional microphone settings and fast-acting compression
Hearing aid features presented in this arm include directional microphone settings and slow-acting compression
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04521166
First Posted
August 17, 2020
Last Updated
October 3, 2023
Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT04521166
Brief Title
Hearing Aid Processing and Working Memory in Realistic Spatial Conditions
Acronym
DIRWDRCWM
Official Title
Investigating the Relationship Between Directional Microphones, Compression, and Working Memory in Realistic Spatial Conditions.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
June 29, 2023 (Actual)
Study Completion Date
June 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
Keywords
hearing aids, directional microphones, cognition, compression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
The participant will be blinded to the hearing aid features being adjusted. The order of presentation of the hearing aid features will be randomized across participants, using a Latin-Square design. The outcomes assessor(s) (who score speech intelligibility) will also be blinded to the conditions.
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Setting 1
Arm Type
Experimental
Arm Description
Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression
Arm Title
Setting 2
Arm Type
Experimental
Arm Description
Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression
Arm Title
Setting 3
Arm Type
Experimental
Arm Description
Hearing aid features presented in this arm include directional microphone settings and fast-acting compression
Arm Title
Setting 4
Arm Type
Experimental
Arm Description
Hearing aid features presented in this arm include directional microphone settings and slow-acting compression
Intervention Type
Device
Intervention Name(s)
Hearing aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Speech intelligibility (percent correct scores)
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varsha Rallapalli, AuD, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Hearing Aid Processing and Working Memory in Realistic Spatial Conditions
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