Subjective and Objective Results With CI Electrode Types
1 other identifier
observational
139
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
November 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedFirst Submitted
Initial submission to the registry
January 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 3, 2018
CompletedMay 3, 2018
May 1, 2018
1.6 years
January 15, 2018
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Intraoperative measurements
Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants.
1 day
Intraoperative measurements
Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants
1 day
Intraoperative measurements
Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants
1 day
Secondary Outcomes (3)
Postoperative measurements
3 months
Postoperative measurements
3 months
Postoperative measurements
3 months
Study Arms (3)
CI532
Patients with CI532 cochlear implant
CI522
Patients with CI522 cochlear implant
CI512
Patients with CI512 cochlear implant
Interventions
Eligibility Criteria
Subjects implanted with CI532 or CI512 or CI522 in Szeged and St. Pölten between the indicated time frames
You may qualify if:
- successful cochlear implantation with CI532 or CI512 or CI522
- gave informed consent
You may not qualify if:
- unsuccessful cochlear implantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery
Szeged, 6725, Hungary
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Head of Otorhinolaryngology Clinic
Study Record Dates
First Submitted
January 15, 2018
First Posted
May 3, 2018
Study Start
November 13, 2015
Primary Completion
June 4, 2017
Study Completion
November 30, 2017
Last Updated
May 3, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share