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Идёт набор NCT07039435

Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

Без фазы С лечением Sensorineural Hearing Loss Cochlear Implantation Perceptual Adaptation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Alternative Frequency Mapping.
Кому может быть актуально
Состояния в реестре: Sensorineural Hearing Loss, Cochlear Implantation, Perceptual Adaptation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users

Обзор

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.

Вмешательства

  • Другое Alternative Frequency Mapping
    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).

Первичные конечные точки

  • Bilateral speech perception as measured by Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score while using standard 188 Hz Frequency-Allocation Table (FAT) [Срок оценки: Baseline]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT [Срок оценки: 1 month post activation of implant]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT [Срок оценки: 3 months post activation of implant]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT [Срок оценки: 6 months post activation of implant]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT [Срок оценки: 12 months post activation of implant]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT [Срок оценки: Baseline]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT [Срок оценки: 1 month post activation of implant]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT [Срок оценки: 3 months post activation of implant]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT [Срок оценки: 6 months post activation of implant]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT [Срок оценки: 12 months post activation of implant]
Вторичные конечные точки (12)
  • Sound Quality Survey score while using standard 188 Hz FAT [Срок оценки: Baseline]
  • Sound Quality Survey score while using standard 188 Hz FAT [Срок оценки: 1 month post activation of implant]
  • Sound Quality Survey score while using standard 188 Hz FAT [Срок оценки: 3 months post activation of implant]
  • Sound Quality Survey score while using standard 188 Hz FAT [Срок оценки: 6 months post activation of implant]
  • Sound Quality Survey score while using standard 188 Hz FAT [Срок оценки: 12 months post activation of implant]
  • Sound Quality Survey score while using standard 313 Hz FAT [Срок оценки: Baseline]
  • Sound Quality Survey score while using standard 313 Hz FAT [Срок оценки: 1 month post activation of implant]
  • Sound Quality Survey score while using standard 313 Hz FAT [Срок оценки: 3 months post activation of implant]
  • Sound Quality Survey score while using standard 313 Hz FAT [Срок оценки: 6 months post activation of implant]
  • Sound Quality Survey score while using standard 313 Hz FAT [Срок оценки: 12 months post activation of implant]
  • Sound Quality Survey score while using standard 438 Hz FAT [Срок оценки: Baseline]
  • Sound Quality Survey score while using standard 438 Hz FAT [Срок оценки: 1 month post activation of implant]

Критерии участия

Критерии включения

  • Age 18 or older
  • No known anatomical abnormalities in either ear
  • English speaking
  • Intends to receive a cochlear implant in one ear (or has already received it but it has not been activated).
  • Normal hearing (or minimal hearing loss) in the contralateral ear

Критерии исключения

  • Under age 18
  • Documented anatomical abnormality of the implanted ear
  • Non-English speaking
  • Greater than minimal hearing loss in the contralateral ear.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • NYU Langone Health — New York

Идентификаторы

NCT: NCT07039435 · 23-01046 · R01DC021980

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗