Clinical trial · Observational
Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users
NCT05300230CI-TRIAL-00057384unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bilateral Sensorineural Hearing Loss | — | UNRESOLVED | — |
| Unilateral Sensorineural Hearing Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neuro Zti cochlear implant and Neuro 2 sound processor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Device: Neuro Zti cochlear implant and Neuro 2 sound processor
Primary outcomes (1)
- 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
- description
- 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 outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.