Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05805384
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
60
1
1
24
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SEDA
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cochlear Implant Users

Participants will complete up to 4 experiments evaluating the use of the Speech Enhancement using Dynamic thresholding Approach (SEDA) algorithm. Each testing session will take between 4-6 hours to complete. Testing sessions will continue until the completion of the experiments.

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

Outcome Measures

Primary Outcome Measures

  1. Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR [Up 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.

  2. Percent of Words Correctly Recognized in Noisy Conditions without NR [Up 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.

  3. Percent of Words Correctly Recognized in Quiet Conditions with SEDA NR [Up 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.

  4. Percent of Words Correctly Recognized in Quiet Conditions without NR [Up 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.

  5. Visual Analogue Scale (VAS) Rating of SEDA NR [Up 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.

  6. Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR [Up 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.

  7. Percent of Words Correctly Recognized in Quiet Conditions with Clinical NR [Up 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.

  8. Percent of Words Correctly Recognized with no SEDA NR [Up 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.

  9. Percent of Words Correctly Recognized with Standard SEDA NR [Up 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.

  10. Percent of Words Correctly Recognized with Low-Computation SEDA NR [Up 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

  11. Percent of Words Correctly Recognized with Very Low-Computation SEDA NR [Up 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tisch Hospital New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: David M. Landsberger, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05805384
Other Study ID Numbers:
  • 22-00815
  • SB1DC018761
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023