NYU Langone Health
New York, 10016, United States
Location status: Recruiting
NCT Number: NCT07039435
The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10016, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will have their speech processors programmed with four maps, three of which use a higher low-frequency cutoff than the default map (313 Hz, 438 Hz, 563 Hz, compared to the default map that has a low-frequency cutoff of 188 Hz).
Time frame: Baseline
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 1 month post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 3 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 6 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 12 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: Baseline
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 1 month post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 3 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 6 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 12 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: Baseline
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 1 month post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 3 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 6 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 12 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: Baseline
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 1 month post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 3 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 6 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: 12 months post activation of implant
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Time frame: Baseline
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 1 month post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 3 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 6 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 12 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: Baseline
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 1 month post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 3 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 6 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 12 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: Baseline
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 1 month post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 3 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 6 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 12 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: Baseline
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 1 month post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 3 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 6 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: 12 months post activation of implant
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame: Baseline
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 1 month post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 3 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 6 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 12 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: Baseline
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 1 month post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 3 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 6 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 12 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: Baseline
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 1 month post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 3 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 6 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 12 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: Baseline
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 1 month post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 3 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 6 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Time frame: 12 months post activation of implant
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Contact information is provided by the study sponsor or research team.
Mario A. Svirsky, PhD
CONTACT
Nicole H. Capach, AuD
CONTACT
NYU Langone Health
Other
Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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