Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT07039435
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perceptual Adaptation Following Cochlear Implantation (Aim 3a)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bilateral speech perception as measured by Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score while using standard 188 Hz Frequency-Allocation Table (FAT)', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': "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."}, {'measure': 'Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': "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."}, {'measure': 'Cochlear Implant (CI)-only speech perception as measured by the consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using standard 188 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using standard 188 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using standard 188 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using standard 188 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': '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.'}, {'measure': 'CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sound Quality Survey score while using standard 188 Hz FAT', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 188 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 188 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 188 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 188 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 313 Hz FAT', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 313 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 313 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 313 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 313 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 438 Hz FAT', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 438 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 438 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 438 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 438 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 563 Hz FAT', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 563 Hz FAT', 'timeFrame': '1 month post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 563 Hz FAT', 'timeFrame': '3 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 563 Hz FAT', 'timeFrame': '6 months post activation of implant', 'description': '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.'}, {'measure': 'Sound Quality Survey score while using standard 563 Hz FAT', 'timeFrame': '12 months post activation of implant', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensorineural Hearing Loss', 'Cochlear Implantation', 'Perceptual Adaptation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older\n2. No known anatomical abnormalities in either ear\n3. English speaking\n4. Intends to receive a cochlear implant in one ear (or has already received it but it has not been activated).\n5. Normal hearing (or minimal hearing loss) in the contralateral ear\n\nExclusion Criteria:\n\n1. Under age 18\n2. Documented anatomical abnormality of the implanted ear\n3. Non-English speaking\n4. Greater than minimal hearing loss in the contralateral ear.'}, 'identificationModule': {'nctId': 'NCT07039435', 'briefTitle': 'Perceptual Adaptation Following Cochlear Implantation (Aim 3a)', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users', 'orgStudyIdInfo': {'id': '23-01046'}, 'secondaryIdInfos': [{'id': 'R01DC021980', 'link': 'https://reporter.nih.gov/quickSearch/R01DC021980', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users', 'description': 'Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care (i.e., 188-7938 Hz for Cochlear users) and the other three will have higher low frequency edges than the standard of care default maps (starting at 313, 438, and 563 Hz, respectively). 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.', 'interventionNames': ['Other: Alternative Frequency Mapping']}], 'interventions': [{'name': 'Alternative Frequency Mapping', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Mario A. Svirsky, PhD', 'role': 'CONTACT', 'email': 'Mario.svirsky@nyulangone.org', 'phone': '646-284-2457'}, {'name': 'Nicole H. Capach, AuD', 'role': 'CONTACT', 'email': 'Nicole.capach@nyulangone.org', 'phone': '646-501-6905'}], 'overallOfficials': [{'name': 'Mario A. Svirsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': "The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: mario.svirsky@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.", 'accessCriteria': "The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to mario.svirsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}