Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users

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Brief Title

Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users

Official Title

Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users

Brief Summary

      The aim of this study is to establish the connection between the cochlear implant programming
      parameters with the auditory effort associated with the speech perception evaluated by
      pupillometry techniques in different audiometric conditions.
    



Study Type

Observational


Primary Outcome

Analyze the correlation between the speech performance in cochlear implant (CI) users, as measured through the percentage of sentence recognition (%) and the auditory effort, measured by peak pupil dilatation (PPD) in mm.

Secondary Outcome

 Evaluate the correlation between the auditory effort as measured through pupillometry techniques and the subjective sensation of the CI patient as rated through validated NASA-TLX questionnaire.

Condition

Bilateral Sensorineural Hearing Loss

Intervention

Neuro Zti cochlear implant and Neuro 2 sound processor

Study Arms / Comparison Groups

 Patients with Zti Opticon Cochlear Implant
Description:  Patients that are users of Neuro Zti and Neuro 2 processor with a minimum of 6 months of habituation after the implementation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

25

Start Date

March 15, 2020

Completion Date

November 15, 2022

Primary Completion Date

July 15, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Users willing to participate in the study with signature and date of the Informed
             Consent.

          -  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:

          -  Speech or language disorder.

          -  Added comorbidities or cognitive dysfunction.

          -  Not approval to participate in the study or absence in some of the programmed sessions
             for the Cochlear Implant.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Serafín Sánchez Gómez, 955 00 80 00, [email protected]

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT05300230

Organization ID

FIS-ZTI-2019-01


Responsible Party

Sponsor

Study Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla


Study Sponsor

Serafín Sánchez Gómez, Principal Investigator, Hospital Universitario Virgen Macarena


Verification Date

March 2022