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

March 17, 2022 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Neuro Zti cochlear implant and Neuro 2 sound processor

The study will consist in 3 visits:

  • Visit 1: it will be carried out the first contact and learning the measurement procedure.
  • Visit 2: it will be evaluated the speech perception and the measurement of the pupil dilatation in silence and noise conditions.
  • Visit 3: it will be analysed the effect of the change in the cochlear implant programming parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
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.
Up to 12 months after the beginning of the study

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 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.
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).
Time Frame: 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)
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.
Time Frame: 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)
Up to 12-36 months after the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Principal Investigator: Serafín Sánchez Gómez, Hospital Universitario Virgen Macarena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2020

Primary Completion (Anticipated)

July 15, 2022

Study Completion (Anticipated)

November 15, 2022

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS-ZTI-2019-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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