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Subjective and Objective Results With CI Electrode Types

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ClinicalTrials.gov Identifier: NCT03515473
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
László Rovó, Szeged University

Brief Summary:

Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.

Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold [ESRT], neural response telemetry threshold [T-NRT] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.


Condition or disease Intervention/treatment
Cochlear Implant Device: cochlear implant

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Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Subjective and Objective Results With CI Electrode Types
Actual Study Start Date : November 13, 2015
Actual Primary Completion Date : June 4, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CI532
Patients with CI532 cochlear implant
Device: cochlear implant
cochlear implant surgery

CI522
Patients with CI522 cochlear implant
Device: cochlear implant
cochlear implant surgery

CI512
Patients with CI512 cochlear implant
Device: cochlear implant
cochlear implant surgery




Primary Outcome Measures :
  1. Intraoperative measurements [ Time Frame: 1 day ]
    Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants.

  2. Intraoperative measurements [ Time Frame: 1 day ]
    Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants

  3. Intraoperative measurements [ Time Frame: 1 day ]
    Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants


Secondary Outcome Measures :
  1. Postoperative measurements [ Time Frame: 3 months ]
    Postoperative neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants

  2. Postoperative measurements [ Time Frame: 3 months ]
    Postoperative comfort level (C-level; current unit) with different types of cochlear implants

  3. Postoperative measurements [ Time Frame: 3 months ]
    Power consumption of different types of cochlear implants



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects implanted with CI532 or CI512 or CI522 in Szeged and St. Pölten between the indicated time frames
Criteria

Inclusion Criteria:

  • successful cochlear implantation with CI532 or CI512 or CI522
  • gave informed consent

Exclusion Criteria:

  • unsuccessful cochlear implantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515473


Locations
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Hungary
Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery
Szeged, Hungary, 6725
Sponsors and Collaborators
Szeged University

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Responsible Party: László Rovó, Professor Head of Otorhinolaryngology Clinic, Szeged University
ClinicalTrials.gov Identifier: NCT03515473     History of Changes
Other Study ID Numbers: CI-001
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by László Rovó, Szeged University:
cochlear implant
CI532
CI512
CI522
electrode array
perimodiolar
electrophysiology