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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Zti Opticon Cochlear Implant | Patients that are users of Neuro Zti and Neuro 2 processor with a minimum of 6 months of habituation after the implementation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuro Zti cochlear implant and Neuro 2 sound processor | Device | The study will consist in 3 visits:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 12 months after the beginning of the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amparo Callejón Leblic | Contact | 955 00 80 00 | amparocallejon@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Serafín Sánchez Gómez | Hospital Universitario Virgen Macarena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41013 | Spain |
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|
| 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 cognitive performance of the CI user as measured by different cognitive tests (Nback, Progressive Matrices, Stroop). | 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) | 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. | 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) | Up to 12-36 months after the beginning of the study |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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