- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02323932
Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Bilateral hearing which is a fundamental characteristic of normal auditory system provides significant advantages in adverse listening conditions. In cochlear implant users, binaural hearing can be achieved via bilateral cochlear implant (CI/CI) or binaural-bimodal stimulation, i.e. a cochlear implant in one ear and a hearing aid in the other (CI/HA). It is assumed that CI/CI hearing and CI/HA hearing differ with respect to their physiological sources and functional benefit. Although both hearing prosthesis (CI/CI or CI/HA) lack several of the features needed to allow listeners to experience the full binaural advantage conferred by a normal-hearing auditory system it can, however, provide significant advantages over the use of a unilateral hearing prosthesis. Most of the accepted assessment clinical materials are not sensitive enough to evaluate the contribution of binaural hearing rehabilitation via CI/CI or CI/HA hearing for the perception of intonation. In a previous study the perception of intonation was evaluated in 29 adults CI/HA users via a closed-set format design with the same target talker. The results of the study showed small bimodal benefit. The test paradigm was apparently an easy task for the adult listeners and not sensitive enough to show the expected CI/HA bimodal benefit over cochlear implant alone.
The perception of correct intonation identification will be computed for each listener in each of the listening conditions. The amount of change in the fundamental frequency that was required in order to identify a question will be computed for each listener in each of the conditions. ANOVA with repeated measures will be used to assess the differences among the conditions for each group as well as the differences among the groups.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Haifa, Izrael
- Rekrutacyjny
- Bnzi Zion Medical Center
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Główny śledczy:
- Michal Luntz, MD
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Kontakt:
- Talma Shpak, PhD
- Numer telefonu: 97248359544
- E-mail: talma.shpak@b-zion.org.il
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Pod-śledczy:
- Noam Yehudai, MD
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Pod-śledczy:
- Talma Shpak, PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Bilateral cochlear implant users
- Bilateral-bimodal users who use hearing aids for at least 75% of their waking hours.
Exclusion Criteria:
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Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Bilateral Cochlear implant users
The perception of intonation will be assessed through the use of 2 tests.
In the first test, listeners will have to identify statements and yes/no questions that will be presented by male and female talkers in the background of four- talkers-babble noise comprised of two females and two males.
In the second test, listeners will be presented with gradual changes in the fundamental frequency of a sentence.
They will be required to identify the sentence with each of the changes as a statement or a question.
Each of the 2 tests will be presented in three listening conditions: each of the CI alone and bilateral (CI/CI) conditions.
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The amount of change in the fundamental frequency that was required in order to identify a question
|
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Aktywny komparator: Bimodal Cochlear implant users
The perception of intonation will be assessed through the use of 2 tests.
In the first test, listeners will have to identify statements and yes/no questions that will be presented by male and female talkers in the background of four- talkers-babble noise comprised of two females and two males.
In the second test, listeners will be presented with gradual changes in the fundamental frequency of a sentence.
They will be required to identify the sentence with each of the changes as a statement or a question.
Each of the 2 tests will be presented in three listening conditions: CI alone, HA alone and bimodal (CI/HA) conditions.
|
The amount of change in the fundamental frequency that was required in order to identify a question
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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The amount of change in the fundamental frequency that was required in order to identify a question
Ramy czasowe: 12 months
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12 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Michal Luntz, MD, Bnai Zion Medical Center
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BZ0085
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