- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02331017
Assessment of Bimodal Contribution in Adult Cochlear Implant Users
Assessment of the Contribution of the Combined Acoustic Hearing Via a Hearing Aid and Electric Hearing Via a Cochlear Implant in Adult Bimodal Users With Moderate to Severe Residual Hearing in the Implanted and Non Implanted Ear.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Many current unilateral Cochlear Implant users have some residual acoustic hearing in the opposite ear as well as in the implanted ear. The amount of useful residual acoustic hearing varies among these implantees. There are several acoustic and electric combinations in the bilateral-bimodal listening mode depending on the amount of useful residual acoustic hearing in each ear. The combination of low frequency acoustic information provided by the hearing aid on each ear, completes the high frequency electric information provided by the Cochlear Implant (complementary bimodal benefit). Each of the different rehabilitation combinationsfor unilateral Cochlear Implant users enablesa unique integration of the three aspects of bilateral hearing bilaterality, binaurality and bimodality which may provide significant advantages over unilateral Cochlear Implant stimulation in terms of speech perception in noise, complementary information as well as localization abilities.
The study will include 20 bilateral-bimodal users with moderate-to-severe hearing loss at 250 Hz, 500 Hz and 1000 Hz in the non-implanted ear, who use hearing aids for at least 75% of their waking hours. Evaluation utilizes bilateral-binaural and bimodal complementary effects task-specific test batteries based on published doctoral research project. The assessment protocol consisted of tests that include various speech materials, different maskers, presentation of the noise from different locations in space, right/left speech lateralization, pitch-related tasks and subjective questionnaires. All tests will be administered in three listening conditions: Cochlear Implant -alone, hearing aid-alone and Cochlear Implant +hearing aid.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Haifa, Israël
- Recrutement
- Bnai Zion Medical Center
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Chercheur principal:
- Michal Luntz, MD
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Contact:
- Talma Shpak, PhD
- Numéro de téléphone: 97248359544
- E-mail: talma.shpak@b-zion.org.il
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Sous-enquêteur:
- Noam Yehudai, MD
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Sous-enquêteur:
- Talma Shpak, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Bilateral-bimodal users
- With moderate-to-severe hearing loss at 250 Hz, 500 Hz and 1000 Hz in the non-implanted ear
- Who use hearing aids for at least 75% of their waking hours
Exclusion Criteria:
-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Bimodal users
Bilateral-bimodal users with moderate-to-severe hearing loss who use hearing aids for at least 75% of their waking hours. Administration of Speech perception tests and self-rating questionnaire |
Speech perception test results and self-rating questionnaire scores will be analyzed by means of non-parametric statistical tests.
The statistical tests will be chosen in accordance with the number and type of variables in each test.
Correlation between audiological variables (aided and unaided hearing thresholds in the non implanted ear, aided speech perception abilities in the HA-alone condition) and the bilateral-bimodal benefit will be examined.
Moreover, possible relationship between self-rating questionnaire scores and speech perception test results will be assessed.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Speech perception task specific tests using assessment protocol which will include 6 speech perception tests in quiet and noise listening conditions.
Délai: 12 months
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ests designed to examine the contribution of bilateral-binaural benefits:
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assessment of functional performance in daily life using self-repot questionnaires
Délai: 12 months
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the Speech, Spatial and Quality (SSQ) questionnaire and the Hearing Handicap Questionnaire (HHQ).
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12 months
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Standard basic speech perception tests
Délai: 12 Months
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Standard basic speech perception tests which will enable to characterize the basic speech perception abilities of the bilateral-bimodal users by means of a commonly utilized assessment tool: monosyllabic word discrimination on the Hebrew version of the AB Word List (HAB) in quiet; Hebrew version of the CID sentence recognition test in quiet and the Hebrew version of the CID sentence recognition test in the presence of four-talker-babble noise with the SNR fixed at +5dB, speech and noise presented from the front.
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12 Months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Michal Luntz, MD, Bnai Zion Medica Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BZ0084
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