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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

Tracking Information
First Submitted Date  ICMJE August 17, 2020
First Posted Date  ICMJE August 20, 2020
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE May 6, 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hearing Aid Processing and Working Memory in Realistic Spatial Conditions
Official Title  ICMJE Investigating the Relationship Between Directional Microphones, Compression, and Working Memory in Realistic Spatial Conditions.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Hearing Loss, Sensorineural
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Setting 1
    Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression
    Intervention: Device: Hearing aid
  • Experimental: Setting 2
    Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression
    Intervention: Device: Hearing aid
  • Experimental: Setting 3
    Hearing aid features presented in this arm include directional microphone settings and fast-acting compression
    Intervention: Device: Hearing aid
  • Experimental: Setting 4
    Hearing aid features presented in this arm include directional microphone settings and slow-acting compression
    Intervention: Device: Hearing aid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Varsha H Rallapalli, AuD, PhD 847-467-0897 halab@northwestern.edu
Contact: Kendra Marks, AuD 847-467-0897 halab@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04521166
Other Study ID Numbers  ICMJE STU00210459
K01DC018324 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Varsha Rallapalli, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Varsha Rallapalli, AuD, PhD Northwestern University
PRS Account Northwestern University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP