Hearing Loss, SensorineuralNCT05599165
Speech Perception in Bimodal Hearing
A study testing signal processing on consonant recognition in people with Hearing Loss, Sensorineural, run by Baylor University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- signal processing on consonant recognition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- signal processing on consonant recognition
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
signal processing on consonant recognitionOther
Consonant recognition will be measured in noise without any signal processing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: signal processing on consonant recognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start25 Oct 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of bimodal cochlear implant users will be tested with three different signal processing for consonant enhancement in noise.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Scott and White Health, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Yang-Soo Yoon, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599165
- Sponsor's protocol ID
- 1001262
- Other IDs
- 1R15DC019240-01A1
- Status last verified
- Oct 2025
- First submitted
- 12 Oct 2022
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Perception Enhancement Using Novel Signal Processing in Bimodal Hearing
- ClinicalTrials.gov ID
- NCT05599165
- Acronym / sponsor ID
- 1001262
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- Baylor Scott and White Health, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of bimodal cochlear implant users will be tested with three different signal processing for consonant enhancement in noise.
| Arm | Type | Receives |
|---|---|---|
| signal processing on consonant recognition | Experimental | Other: signal processing on consonant recognitionThe 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| signal processing on consonant recognitionConsonant recognition will be measured in noise without any signal processing. | Other | signal processing on consonant recognition |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang-Soo Yoon, PhD principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing signal processing on consonant recognition in people with Hearing Loss, Sensorineural, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bimodal benefit in percent correct scores for consonant perception with three signal processing conditions (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.