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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05599165
Other study ID # 1001262
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 25, 2021
Est. completion date August 31, 2024

Study information

Verified date October 2022
Source Baylor University
Contact Yang-Soo Yoon, PhD
Phone 254-710-6364
Email yang-soo_yoon@baylor.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5
Est. completion date August 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 74 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Different signal processing for consonant recognition
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.

Locations

Country Name City State
United States Yang-Soo Yoon Waco Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor University Baylor Scott and White Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 weeks
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