NCT05599165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

3.8 years

First QC Date

October 12, 2022

Last Update Submit

October 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

signal processing on consonant recognition

EXPERIMENTAL

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.

Other: signal processing on consonant recognition

Interventions

Consonant recognition will be measured in noise without any signal processing.

signal processing on consonant recognition

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yang-Soo Yoon, PhD

    Baylor University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: A single group of bimodal cochlear implant users will be tested with three different signal processing for consonant enhancement in noise.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 31, 2022

Study Start

October 25, 2021

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations