Clinical trial NCT05300230: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bilateral Sensorineural Hearing Loss
Unilateral Sensorineural Hearing Loss
Keywords: Bilateral Sensorineural Hearing Loss
Unilateral Sensorineural Hearing Loss
Moderate
Severe
Zti Cochlear implant
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the Virgen Macarena Hospital of Seville that are users of the Neuro Zti and Neuro 2 processor with at least 6 months of habituation after the implementation.

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.


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.

Primary outcomes:
measure: 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.
timeFrame: Up to 12 months after the beginning of the study
Secondary outcomes:
measure: 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.
timeFrame: Up to 12-24 months after the beginning of the study
measure: Evaluate the correlation between the auditory effort as measured through pupillometry techniques and the cognitive performance of the CI user as measured by different cognitive tests (Nback, Progressive Matrices, Stroop).
timeFrame: Up to 12-24 months after the beginning of the study
measure: Analyze the differences between the auditory effort, as measured through pupillometry techniques in two different CI programming conditions.
timeFrame: Up to 12-36 months after the beginning of the study
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Serafín Sánchez Gómez
role: PRINCIPAL_INVESTIGATOR
References: