Improving Spatial Perception and Speech Understanding in Multitalker Mixtures

Hearing Loss Clinical Trial

Official title:

Improving Spatial Perception and Speech Understanding in Multitalker Mixtures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260307
• Other study ID #: 4218E
• Secondary ID: R01DC015760
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: November 30, 2026

Study information

• Verified date: November 2022
• Source: Boston University Charles River Campus
• Contact: Virginia A Best, PhD
• Phone: (617) 353-2622
• Email: ginbest[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Other:
• hearing aid condition
The intervention will be a hearing aid or a modification to the sound stimulus that simulates a hearing aid configuration, style, or processing strategy.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%).	Baseline
Primary	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%).	Up to 4 hours
Primary	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).	Baseline
Primary	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).	Up to 4 hours
Primary	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.	Baseline
Primary	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.	Up to 4 hours
Primary	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%).	Baseline
Primary	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%).	Up to 4 hours