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Speech Perception in Bimodal Hearing

Primary Purpose

Hearing Loss, Sensorineural

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Different signal processing for consonant recognition
Sponsored by
Baylor University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The proposed work requires the following qualifications to be met: be age from 18-74 years old, be native speakers of American English, be post-lingually deafened in both ears, be healthy enough to manipulate a computer mouse and read information on a computer monitor, and have at least 1-year of bimodal use prior to initiation of study participation to account for continuous improvement. Exclusion Criteria: Subjects that cannot speak, are unable to read information on a computer monitor, and/or cannot manipulate a computer mouse are not eligible for this study. Our study will also exclude participants under the age of 18.

Sites / Locations

  • Yang-Soo YoonRecruiting

Outcomes

Primary Outcome Measures

Bimodal benefit in percent correct scores for consonant perception with three signal processing conditions
Percent correct scores, ranging from minimum 0% to maximum 100% in consonant perception scores will be compared under three signal processing conditions: (1) when no signal processing is applied to consonants (baseline), (2) when the target frequency and time ranges responsible for consonant perception are intensified, and (3) when the conflicting frequency and time ranges causing consonant confusions are removed. Higher percent correct scores mean a better outcome.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2022
Last Updated
October 25, 2022
Sponsor
Baylor University
Collaborators
Baylor Scott and White Health
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1. Study Identification

Unique Protocol Identification Number
NCT05599165
Brief Title
Speech Perception in Bimodal Hearing
Official Title
Speech Perception Enhancement Using Novel Signal Processing in Bimodal Hearing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor University
Collaborators
Baylor Scott and White Health

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 protocol has two aims; Aim 1 involves two experiments and Aim 2 involves three experiments. Under Aim 1, the investigator will identify that the frequency and time ranges of consonants produce consonant enhancement (i.e., "target frequency range" and "target time range", respectively), and that the frequency and time ranges of consonants cause consonant confusions (i.e., "conflicting frequency range" and "conflicting time range", respectively). Aim 2 tests the effects of the frequency and time ranges, identified through Aim 1 on consonant recognition with each of the four signal processing conditions: no signal processing (i.e., control condition), the target frequency and time ranges intensified alone, the conflicting frequency and time ranges suppressed alone, and both target range intensification and conflicting range suppression.
Detailed Description
Speech perception for those who use cochlear implants (CIs) in combination with hearing aids (HAs) in opposite ears (i.e., bimodal hearing) varies greatly. This variability depends on the users' ability to process frequency and time information critical for speech perception. By identifying and enhancing this acoustic information, speech perception will significantly improve. In this AREA project, the investigators aim to establish and verify a tailored identification scheme for the spectral and temporal cues responsible for consonant recognition. The recent bimodal study conducted in the investigator's research laboratory shows that some frequency ranges and time segments of consonants are critical for consonant enhancement (called "target frequency or time ranges") while other frequency and time ranges cause consonant confusions (called "conflicting frequency or time ranges"). An Articulation Index-Gram (AI-Gram) signal processing can add and suppress intensity on these target and conflicting ranges. In Aim 1, the investigators will determine the effect of the dead regions on consonant recognition. Target and conflicting ranges will then be identified on an individual subject basis for each consonant in the HA alone, CI alone, and CI+HA in quiet. The target frequency range will be determined by finding the frequency regions creating dramatic consonant enhancement, while the conflicting frequency ranges will be determined by finding the frequency regions creating consonant confusion. The target time ranges will be determined by finding the segment of the consonants responsible for dramatic consonant improvement while systematically truncating the consonant. The target time range will be used as the conflicting time ranges because the conflicting frequency ranges would be the most detrimental factor affecting the target frequency ranges if they coincide in time. In Aim 2, consonant recognition will be measured in quiet and noise under the three AI-Gram processing conditions: 1) target ranges alone with +6 dB gain; 2) conflicting ranges alone with -6 dB suppression; and 3) both intensified target and suppressed conflicting ranges. For each AI-Gram processing condition, consonant recognition will be measured in the matched listening conditions (e.g., the target or conflicting ranges identified in the HA alone will be presented in the HA alone listening condition). To determine how the unilateral detection ability affects bimodal benefit, the consonants processed on the target or conflicting ranges identified in the HA alone and CI alone will each be presented to the CI+HA listening condition. This proposed work will identify acoustic cues that contribute to bimodal benefit and will reveal how these cues are integrated or interfered with across modalities. Defining the relative impact of the target and conflicting ranges on the AI-Gram-sensitive consonants in the HA alone, the CI alone, and the CI+HA together will help determine the upper and lower cutoff frequencies of a HA and a CI and fine-tune these cutoff frequencies. This data is much needed for the long-term goal: developing a tailored bimodal fitting procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Different signal processing for consonant recognition
Intervention Description
Consonant recognition will be measured in noise with three different signal processing conditions: control (no signal processing), important frequency regions enhanced by signal processing, and combined conditions of important frequency regions enhanced and confused frequency regions removed by signal processing.
Primary Outcome Measure Information:
Title
Bimodal benefit in percent correct scores for consonant perception with three signal processing conditions
Description
Percent correct scores, ranging from minimum 0% to maximum 100% in consonant perception scores will be compared under three signal processing conditions: (1) when no signal processing is applied to consonants (baseline), (2) when the target frequency and time ranges responsible for consonant perception are intensified, and (3) when the conflicting frequency and time ranges causing consonant confusions are removed. Higher percent correct scores mean a better outcome.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The proposed work requires the following qualifications to be met: be age from 18-74 years old, be native speakers of American English, be post-lingually deafened in both ears, be healthy enough to manipulate a computer mouse and read information on a computer monitor, and have at least 1-year of bimodal use prior to initiation of study participation to account for continuous improvement. Exclusion Criteria: Subjects that cannot speak, are unable to read information on a computer monitor, and/or cannot manipulate a computer mouse are not eligible for this study. Our study will also exclude participants under the age of 18.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang-Soo Yoon, PhD
Phone
254-710-6364
Email
yang-soo_yoon@baylor.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang-Soo Yoon, PhD
Organizational Affiliation
Baylor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yang-Soo Yoon
City
Waco
State/Province
Texas
ZIP/Postal Code
76798
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang-Soo Yoon
Phone
254-710-6364
Email
yang-soo_yoon@baylor.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Speech Perception in Bimodal Hearing

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