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

• Conditions: Bilateral Sensorineural Hearing Loss; Unilateral Sensorineural Hearing Loss
• Interventions: Device: Neuro Zti cochlear implant and Neuro 2 sound processor

• Registration Number: NCT05300230
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-11
• Study Start: 2020-03-15
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-07-15
• Study Completion: 2022-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	Up to 12 months after the beginning of the study	The speech perception will be evaluated through validated sentence recognition tests (such as the HINT test) and the result will be the percentage of correct sentences repeated by the CI patient. The listening effort will be measured through pupillometry techniques in scenarios with different audiometric conditions (different SNR). The result will be the peak pupil dilation in mm.

Secondary Outcome Measures

Name	Time	Method
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).	Up to 12-24 months after the beginning of the study	Analyze the correlation between the objetive auditory effort as measured through pupillometry techniques (peak pupil dilatation, PPD in mm) and the cognitive performance of the CI patient as measured through cognitive tests (Nback, Progressive Matrices, Stroop)
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.	Up to 12-24 months after the beginning of the study	Analyze the correlation between the objetive auditory effort as measured through pupillometry techniques (peak pupil dilatation, PPD in mm) and the subjetive feeling of effort (fatigue, etc.) as rated by the CI patient in NASA-TLX questionnaire.
Analyze the differences between the auditory effort, as measured through pupillometry techniques in two different CI programming conditions.	Up to 12-36 months after the beginning of the study	Compare the auditory effort made by the CI patients, as measured by pupillometry techniques, i.e., the peak pupil dilatation (PPD in mm) over two different CI programming conditions: the first condition with the noise filter capability of the CI processor in off mode (VoiceTrack OFF) and the second condition with the noise filters in ON mode (VoiceTrack ON)

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain