- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05260307
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Virginia A Best, PhD
- Phone Number: (617) 353-2622
- Email: ginbest@bu.edu
Study Contact Backup
- Name: Christine Mason
- Phone Number: cmason@bu.edu
- Email: cmason@bu.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Boston University
-
Contact:
- Virginia Best
- Phone Number: 617-353-2622
- Email: ginbest@bu.edu
-
Principal Investigator:
- Virginia A Best, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Experimental condition
Participants will be presented with sound stimuli under a number of experimental conditions that simulate different hearing-aid conditions.
|
The intervention will be a hearing aid or a modification to the sound stimulus that simulates a hearing aid configuration, style, or processing strategy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech intelligibility at baseline
Time Frame: 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%).
|
Baseline
|
|
Speech intelligibility post-intervention
Time Frame: Up to 4 hours
|
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%).
|
Up to 4 hours
|
|
Speech reception threshold at baseline
Time Frame: 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).
|
Baseline
|
|
Speech reception threshold post-intervention
Time Frame: Up to 4 hours
|
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).
|
Up to 4 hours
|
|
Interaural time difference discrimination at baseline
Time Frame: 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.
|
Baseline
|
|
Interaural time difference discrimination post-intervention
Time Frame: Up to 4 hours
|
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.
|
Up to 4 hours
|
|
Externalization rating at baseline
Time Frame: 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%).
|
Baseline
|
|
Externalization rating post-intervention
Time Frame: Up to 4 hours
|
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%).
|
Up to 4 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Virginia A Best, PhD, Boston University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4218E
- R01DC015760 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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