AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

United States1 site
  • Baylor University

    Waco, Texas, 76798

Other trials in United States

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.

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 groups in NCT05599165
Study groupRoleWhat they receive
signal processing on consonant recognitionExperimentalThe 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.

  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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start25 Oct 2021
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in