Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
Primary Purpose
Hearing Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SEDA
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Impairment
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.
Sites / Locations
- Tisch HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cochlear Implant Users
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05805384
First Posted
March 23, 2023
Last Updated
March 23, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT05805384
Brief Title
Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
Official Title
Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cochlear Implant Users
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SEDA
Intervention Description
Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise.
Primary Outcome Measure Information:
Title
Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 1.1)
Title
Percent of Words Correctly Recognized in Noisy Conditions without NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 1.1)
Title
Percent of Words Correctly Recognized in Quiet Conditions with SEDA NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 1.1)
Title
Percent of Words Correctly Recognized in Quiet Conditions without NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 1.1)
Title
Visual Analogue Scale (VAS) Rating of SEDA NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 1.2)
Title
Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 2)
Title
Percent of Words Correctly Recognized in Quiet Conditions with Clinical NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 2)
Title
Percent of Words Correctly Recognized with no SEDA NR
Description
Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized without SEDA NR.
Time Frame
Up to Year 2 (Completion of Experiment 4)
Title
Percent of Words Correctly Recognized with Standard SEDA NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 4)
Title
Percent of Words Correctly Recognized with Low-Computation SEDA NR
Description
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
Time Frame
Up to Year 2 (Completion of Experiment 4)
Title
Percent of Words Correctly Recognized with Very Low-Computation SEDA NR
Description
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.
Time Frame
Up to Year 2 (Completion of Experiment 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David M. Landsberger
Phone
212-263-8455
Email
David.landsberger@nyulangone.com
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Stupak
Phone
646-501-4153
Email
Natalia.stupak@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Landsberger
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.landsberger@nyulangone.com. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.landsberger@nyulangone.com. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
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