Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hearing aid condition
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss focused on measuring Hearing Aids, Speech Intelligibility, Spatial Hearing, Cocktail Party, Audibility, Sound Image Externalization, Speech Envelope
Eligibility Criteria
Inclusion Criteria: Normal-Hearing Subjects
- 18 to 35 years of age
- Audiometric thresholds that do not exceed 20 dB HL at any frequency from 250 to 8000 Hz
- Able to provide informed consent and understand experimental instructions
- Normal or corrected-to-normal vision
Inclusion Criteria: Hearing-Impaired Subjects
- 18 to 80 years of age
- Documented sensorineural hearing loss
- Able to provide informed consent and understand experimental instructions
- Normal or corrected-to-normal vision
Exclusion Criteria (some experiments)
- Non-native speakers of English
Sites / Locations
- Boston UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Experimental condition
Arm Description
Participants will be presented with sound stimuli under a number of experimental conditions that simulate different hearing-aid conditions.
Outcomes
Primary Outcome Measures
Speech intelligibility at baseline
Speech intelligibility scores will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in percent correct (0-100%).
Speech intelligibility post-intervention
Speech intelligibility scores will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in percent correct (0-100%).
Speech reception threshold at baseline
Speech reception thresholds will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in decibels (the level of the target speech relative to the masker speech needed to identify 50% of the words in a sentence).
Speech reception threshold post-intervention
Speech reception thresholds will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in decibels (the level of the target speech relative to the masker speech needed to identify 50% of the words in a sentence).
Interaural time difference discrimination at baseline
Thresholds for the discrimination of interaural time differences in speech will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in microseconds.
Interaural time difference discrimination post-intervention
Thresholds for the discrimination of interaural time differences in speech will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in microseconds.
Externalization rating at baseline
Externalization judgments for speech will be measured in a baseline condition (e.g. unaided) and in a number of different hearing-aid conditions (post-intervention). Scale is in percent (0-100%).
Externalization rating post-intervention
Externalization judgments for speech will be measured in a baseline condition (e.g. unaided) and in a number of different hearing-aid conditions (post-intervention). Scale is in percent (0-100%).
Secondary Outcome Measures
Full Information
NCT ID
NCT05260307
First Posted
February 4, 2022
Last Updated
November 16, 2022
Sponsor
Boston University Charles River Campus
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT05260307
Brief Title
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Official Title
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization.
Detailed Description
The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. Aim 1 will investigate how well different amplification strategies provide access to the spectrotemporally sparse speech information that is available in multitalker mixtures. The hypothesis is that subtle differences in high-frequency audibility across different strategies may have much greater effects on the intelligibility of sparse speech than intact speech. This Aim will involve 40 subjects with hearing loss across 2 experiments. Aim 2 is an exploratory aim that will investigate the potential of a speech enhancement algorithm to improve spatial hearing in multitalker mixtures. The hypothesis is that speech enhancement, in addition to its established monaural benefits, will enhance the salience of interaural time differences and thus provide binaural benefits in multitalker mixtures. This Aim will involve 30 subjects with normal hearing and 60 subjects with hearing loss across 3 experiments. Aim 3 will investigate how different hearing-aid styles affect sound externalization. The hypothesis is that hearing aids can disrupt sound externalization, which in turn impacts speech intelligibility in multitalker mixtures. This Aim will involve 30 subjects with normal hearing and 60 subjects with hearing loss across 3 experiments.
This is a prospective design involving adult human subjects. While the investigators will recruit subjects with normal and impaired hearing, all subjects will be assigned to the same set of experimental conditions. Therefore, for the purposes of intervention (or prospective assignment), the subjects can be treated as a single group completing the same intervention (or set of interventions). The behavioral experiments involve listening to speech sounds (either unaided, with hearing aids, or with simulated hearing aids), and providing responses related to spatial perception or speech intelligibility. The order of experimental conditions will be randomized for each subject in order to control for order effects. All of the experimental tasks and outcome measures have been previously established, have good reliability and validity, and will be appropriate for informing future studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing Aids, Speech Intelligibility, Spatial Hearing, Cocktail Party, Audibility, Sound Image Externalization, Speech Envelope
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will be tested under a number of experimental conditions that simulate different hearing aid conditions. They will act as their own control.
Masking
None (Open Label)
Masking Description
While participants will not be informed about the specific experimental condition being tested, certain acoustical changes may be perceptible to them and thus strict masking is impossible.
Allocation
N/A
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental condition
Arm Type
Other
Arm Description
Participants will be presented with sound stimuli under a number of experimental conditions that simulate different hearing-aid conditions.
Intervention Type
Other
Intervention Name(s)
hearing aid condition
Intervention Description
The intervention will be a hearing aid or a modification to the sound stimulus that simulates a hearing aid configuration, style, or processing strategy.
Primary Outcome Measure Information:
Title
Speech intelligibility at baseline
Description
Speech intelligibility scores will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in percent correct (0-100%).
Time Frame
Baseline
Title
Speech intelligibility post-intervention
Description
Speech intelligibility scores will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in percent correct (0-100%).
Time Frame
Up to 4 hours
Title
Speech reception threshold at baseline
Description
Speech reception thresholds will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in decibels (the level of the target speech relative to the masker speech needed to identify 50% of the words in a sentence).
Time Frame
Baseline
Title
Speech reception threshold post-intervention
Description
Speech reception thresholds will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in decibels (the level of the target speech relative to the masker speech needed to identify 50% of the words in a sentence).
Time Frame
Up to 4 hours
Title
Interaural time difference discrimination at baseline
Description
Thresholds for the discrimination of interaural time differences in speech will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in microseconds.
Time Frame
Baseline
Title
Interaural time difference discrimination post-intervention
Description
Thresholds for the discrimination of interaural time differences in speech will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in microseconds.
Time Frame
Up to 4 hours
Title
Externalization rating at baseline
Description
Externalization judgments for speech will be measured in a baseline condition (e.g. unaided) and in a number of different hearing-aid conditions (post-intervention). Scale is in percent (0-100%).
Time Frame
Baseline
Title
Externalization rating post-intervention
Description
Externalization judgments for speech will be measured in a baseline condition (e.g. unaided) and in a number of different hearing-aid conditions (post-intervention). Scale is in percent (0-100%).
Time Frame
Up to 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal-Hearing Subjects
18 to 35 years of age
Audiometric thresholds that do not exceed 20 dB HL at any frequency from 250 to 8000 Hz
Able to provide informed consent and understand experimental instructions
Normal or corrected-to-normal vision
Inclusion Criteria: Hearing-Impaired Subjects
18 to 80 years of age
Documented sensorineural hearing loss
Able to provide informed consent and understand experimental instructions
Normal or corrected-to-normal vision
Exclusion Criteria (some experiments)
Non-native speakers of English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Virginia A Best, PhD
Phone
(617) 353-2622
Email
ginbest@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Mason
Phone
cmason@bu.edu
Email
cmason@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia A Best, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Best
Phone
617-353-2622
Email
ginbest@bu.edu
First Name & Middle Initial & Last Name & Degree
Virginia A Best, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie results in a publication will be made publicly available.
IPD Sharing Time Frame
The data will be made available at the time of the relevant publication.
Learn more about this trial
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
We'll reach out to this number within 24 hrs