Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users
Overview
- Phase
- Not Applicable
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- 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.
Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- 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)
- 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 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)