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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05805384
Other study ID # 22-00815
Secondary ID SB1DC018761
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date March 1, 2025

Study information

Verified date January 2024
Source NYU Langone Health
Contact David M. Landsberger
Phone 212-263-8455
Email David.landsberger@nyulangone.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Tisch Hospital New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR 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. Up to Year 2 (Completion of Experiment 1.1)
Primary Percent of Words Correctly Recognized in Noisy Conditions without NR 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. Up to Year 2 (Completion of Experiment 1.1)
Primary Percent of Words Correctly Recognized in Quiet Conditions with SEDA NR 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. Up to Year 2 (Completion of Experiment 1.1)
Primary Percent of Words Correctly Recognized in Quiet Conditions without NR 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. Up to Year 2 (Completion of Experiment 1.1)
Primary Visual Analogue Scale (VAS) Rating of SEDA NR 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. Up to Year 2 (Completion of Experiment 1.2)
Primary Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR 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. Up to Year 2 (Completion of Experiment 2)
Primary Percent of Words Correctly Recognized in Quiet Conditions with Clinical NR 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. Up to Year 2 (Completion of Experiment 2)
Primary Percent of Words Correctly Recognized with no SEDA NR Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized without SEDA NR. Up to Year 2 (Completion of Experiment 4)
Primary Percent of Words Correctly Recognized with Standard SEDA NR 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. Up to Year 2 (Completion of Experiment 4)
Primary Percent of Words Correctly Recognized with Low-Computation SEDA NR 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 Up to Year 2 (Completion of Experiment 4)
Primary Percent of Words Correctly Recognized with Very Low-Computation SEDA NR 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. Up to Year 2 (Completion of Experiment 4)
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