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Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05805384
Enrollment
60
Registered
2023-04-10
Start date
2023-03-01
Completion date
2027-03-01
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Impairment

Brief summary

In this study, a noise reduction algorithm will be implemented in various listening situations to evaluate its effectiveness in improving speech understanding for cochlear implant users ages 12 and older.

Interventions

DEVICESEDA

Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise.

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* At least 12 years of age. * Be post-lingually deafened cochlear implant recipients with at least 6 months experience regardless of manufacturer. * The PI must also deem the child to be developmentally able to complete the experiments.

Exclusion criteria

• Anyone who is not a cochlear implant user or is aged under 12 years.

Design outcomes

Primary

MeasureTime frameDescription
Percent of Words Correctly Recognized in Noisy Conditions with SEDA NRUp to Year 2 (Completion of Experiment 1.1)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in noisy listening conditions while using the SEDA Noise Reduction (NR) algorithm.
Percent of Words Correctly Recognized in Noisy Conditions without NRUp to Year 2 (Completion of Experiment 1.1)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in noisy listening conditions without SEDA NR.
Percent of Words Correctly Recognized in Quiet Conditions with SEDA NRUp to Year 2 (Completion of Experiment 1.1)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in quiet listening conditions while using the SEDA NR.
Percent of Words Correctly Recognized in Quiet Conditions without NRUp to Year 2 (Completion of Experiment 1.1)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in quiet listening conditions with SEDA NR.
Visual Analogue Scale (VAS) Rating of SEDA NRUp to Year 2 (Completion of Experiment 1.2)Participants will be presented with two buttons: one button will play a sample with SEDA NR and the other will play a sample without SEDA NR. Listeners will report which sample was preferable by clicking on a horizontal visual analog scale (VAS). VAS ratings will be scored on a scale of -10 to 10 where positive numbers indicate a preference for SEDA NR and negative numbers indicate a preference for not using SEDA NR. The magnitude of the absolute value of the score indicates the strength of the preference.
Percent of Words Correctly Recognized in Noisy Conditions with Clinical NRUp to Year 2 (Completion of Experiment 2)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in noisy listening conditions while using a clinical NR algorithm.
Percent of Words Correctly Recognized in Quiet Conditions with Clinical NRUp to Year 2 (Completion of Experiment 2)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in quite listening conditions while using a clinical NR algorithm.
Percent of Words Correctly Recognized with no SEDA NRUp to Year 2 (Completion of Experiment 4)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized without SEDA NR.
Percent of Words Correctly Recognized with Standard SEDA NRUp to Year 2 (Completion of Experiment 4)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized with Standard SEDA NR.
Percent of Words Correctly Recognized with Low-Computation SEDA NRUp to Year 2 (Completion of Experiment 4)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized with the Low-Computation SEDA NR, which is designed to have minimal computation while maintaining an Extended Short-Time Objective Intelligibility Predictor (ESTOI) value similar to the standard SEDA implementation
Percent of Words Correctly Recognized with Very Low-Computation SEDA NRUp to Year 2 (Completion of Experiment 4)Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized with the Very Low-Computation SEDA NR, which is designed to have a reasonable ESTOI value with minimal computational requirements.

Countries

United States

Contacts

Primary ContactDavid M. Landsberger
David.landsberger@nyulangone.com212-263-8455
Backup ContactNatalia Stupak
Natalia.stupak@nyulangone.org646-501-4153

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026