Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

Study 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.

Official Title
-----------------
Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

Conditions
-----------------
Hearing Impairment

Intervention / Treatment
-----------------
* Device: SEDA


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cochlear Implant Users<br>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<br>* Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |