- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02323932
Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Haifa, Israel
- Rekruttering
- Bnzi Zion Medical Center
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Hovedetterforsker:
- Michal Luntz, MD
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Ta kontakt med:
- Talma Shpak, PhD
- Telefonnummer: 97248359544
- E-post: talma.shpak@b-zion.org.il
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Underetterforsker:
- Noam Yehudai, MD
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Underetterforsker:
- Talma Shpak, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
|
Hva måler studien?
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
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michal Luntz, MD, Bnai Zion Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BZ0085
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