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

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ClinicalTrials.gov Identifier: NCT04521166
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Varsha Rallapalli, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Device: Hearing aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
Official Title: Investigating the Relationship Between Directional Microphones, Compression, and Working Memory in Realistic Spatial Conditions.
Actual Study Start Date : May 6, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids Memory

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521166


Contacts
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Contact: Varsha H Rallapalli, AuD, PhD 847-467-0897 halab@northwestern.edu
Contact: Kendra Marks, AuD 847-467-0897 halab@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Varsha Rallapalli, Au.D, Ph.D    847-467-0897    varsha.rallapalli@northwestern.edu   
Contact: Kendra Marks, Au.D    847-467-0897    kendra.marks@northwestern.edu   
Principal Investigator: Varsha Rallapalli, Au.D, Ph.D         
Sponsors and Collaborators
Northwestern University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Varsha Rallapalli, AuD, PhD Northwestern University
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Responsible Party: Varsha Rallapalli, Postdoctoral Fellow, Northwestern University
ClinicalTrials.gov Identifier: NCT04521166    
Other Study ID Numbers: STU00210459
K01DC018324 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Varsha Rallapalli, Northwestern University:
hearing aids
directional microphones
cognition
compression
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases