Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SB1DC018761 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear Implant Users | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEDA | Device | Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise. |
|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Anyone who is not a cochlear implant user or is aged under 12 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David M. Landsberger | Contact | 212-263-8455 | David.landsberger@nyulangone.com | |
| Natalia Stupak | Contact | 646-501-4153 | Natalia.stupak@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| David M. Landsberger | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tisch Hospital | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |