Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users
NCT ID: NCT05300230
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2020-03-15
2022-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with Zti Opticon Cochlear Implant
Patients that are users of Neuro Zti and Neuro 2 processor with a minimum of 6 months of habituation after the implementation.
Neuro Zti cochlear implant and Neuro 2 sound processor
The study will consist in 3 visits:
* Visit 1: it will be carried out the first contact and learning the measurement procedure.
* Visit 2: it will be evaluated the speech perception and the measurement of the pupil dilatation in silence and noise conditions.
* Visit 3: it will be analysed the effect of the change in the cochlear implant programming parameters.
Interventions
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Neuro Zti cochlear implant and Neuro 2 sound processor
The study will consist in 3 visits:
* Visit 1: it will be carried out the first contact and learning the measurement procedure.
* Visit 2: it will be evaluated the speech perception and the measurement of the pupil dilatation in silence and noise conditions.
* Visit 3: it will be analysed the effect of the change in the cochlear implant programming parameters.
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 70 years old.
* At least 6 months experience with the Neuro Zti implant and Neuro 2 processor.
* Unilateral, bilateral and bimodal users.
* Basic understanding of oral and written Spanish.
* Normal or corrected vision.
Exclusion Criteria
* Added comorbidities or cognitive dysfunction.
* Not approval to participate in the study or absence in some of the programmed sessions for the Cochlear Implant.
18 Years
70 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Serafín Sánchez Gómez
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena
Locations
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Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIS-ZTI-2019-01
Identifier Type: -
Identifier Source: org_study_id
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