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Clinical Trials/NCT05805384
NCT05805384
Recruiting
Not Applicable

Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

NYU Langone Health1 site in 1 country60 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Impairment
Sponsor
NYU Langone Health
Enrollment
60
Locations
1
Primary Endpoint
Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
March 1, 2027
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR

Time Frame: 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.

Percent of Words Correctly Recognized in Quiet Conditions with Clinical NR

Time Frame: 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.

Percent of Words Correctly Recognized with Very Low-Computation SEDA NR

Time Frame: 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.

Visual Analogue Scale (VAS) Rating of SEDA NR

Time Frame: 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.

Percent of Words Correctly Recognized with no SEDA NR

Time Frame: 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.

Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR

Time Frame: 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.

Percent of Words Correctly Recognized in Quiet Conditions with SEDA NR

Time Frame: 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.

Percent of Words Correctly Recognized in Quiet Conditions without NR

Time Frame: 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.

Percent of Words Correctly Recognized in Noisy Conditions without NR

Time Frame: 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.

Percent of Words Correctly Recognized with Standard SEDA NR

Time Frame: 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.

Percent of Words Correctly Recognized with Low-Computation SEDA NR

Time Frame: 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

Study Sites (1)

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