Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

Hearing Impairment Clinical Trial

Official title:

Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805384
• Other study ID #: 22-00815
• Secondary ID: SB1DC018761
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

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)