- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05599165
Speech Perception in Bimodal Hearing
October 16, 2025 updated by: Baylor University
Speech Perception Enhancement Using Novel Signal Processing in Bimodal Hearing
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Waco, Texas, United States, 76798
- Baylor University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: signal processing on consonant recognition
The effects of the three processing schemes on consonant enhancement will be measured. The results will be compared with two signal processing schemes: target-cue signal processing, and combined target and conflict-cue signal processing. |
Consonant recognition will be measured in noise without any signal processing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bimodal benefit in percent correct scores for consonant perception with three signal processing conditions
Time Frame: 24 weeks
|
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.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yang-Soo Yoon, PhD, Baylor University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2021
Primary Completion (Actual)
July 31, 2025
Study Completion (Actual)
July 31, 2025
Study Registration Dates
First Submitted
October 12, 2022
First Submitted That Met QC Criteria
October 25, 2022
First Posted (Actual)
October 31, 2022
Study Record Updates
Last Update Posted (Estimated)
October 21, 2025
Last Update Submitted That Met QC Criteria
October 16, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1001262
- 1R15DC019240-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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