- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02323932
Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Haifa, Israel
- Rekruttering
- Bnzi Zion Medical Center
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Ledende efterforsker:
- Michal Luntz, MD
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Kontakt:
- Talma Shpak, PhD
- Telefonnummer: 97248359544
- E-mail: talma.shpak@b-zion.org.il
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Underforsker:
- Noam Yehudai, MD
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Underforsker:
- Talma Shpak, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Bilateral cochlear implant users
- Bilateral-bimodal users who use hearing aids for at least 75% of their waking hours.
Exclusion Criteria:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv 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.
|
The amount of change in the fundamental frequency that was required in order to identify a question
|
|
Aktiv 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The amount of change in the fundamental frequency that was required in order to identify a question
Tidsramme: 12 months
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12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michal Luntz, MD, Bnai Zion Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BZ0085
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