NCT05300230

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
2 years until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

February 11, 2020

Last Update Submit

March 17, 2022

Conditions

Bilateral Sensorineural Hearing LossUnilateral Sensorineural Hearing Loss

Keywords

Bilateral Sensorineural Hearing LossUnilateral Sensorineural Hearing LossModerateSevereZti Cochlear implant

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • 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 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

Study Arms (1)

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

Interventions

Neuro Zti cochlear implant and Neuro 2 sound processorDEVICE

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.

Patients with Zti Opticon Cochlear Implant

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Serafín Sánchez Gómez

    Hospital Universitario Virgen Macarena

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amparo Callejón Leblic

CONTACT

955 00 80 00amparocallejon@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

March 29, 2022

Study Start

March 15, 2020

Primary Completion

July 15, 2022

Study Completion

November 15, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

ES(1)