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