CT Guided CI Programming (NCT04506424) | Clinical Trial Compass
CompletedNot Applicable
CT Guided CI Programming
United States19 participantsStarted 2021-09-01
Plain-language summary
The current standard of care for cochlear implants (CI) does not address the significant pitch-place mismatch that is inherent in cochlear implantation (see detailed description below). The present study uses postoperative Flat Panel (higher resolution than standard) CT imaging to measure where CI electrodes sit within an individual's cochlea; doing so allows for more accurate frequency mapping (and thus pitch perception). The hypothesis of this study is that long-term (1 year) use of CT image-based frequency maps, beginning on the first day of CI activation, will improve user performance in the areas of speech and music perception, as compared to the use of default programming settings.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has or plans to have a MED-EL cochlear implant (CI)
* Has not yet had their CI activated
* Be able and willing to participate in all of the research appointments for follow-up testing (e.g., 1, 3, 6, 12, and 13 months post-CI activation)
* Be willing to use the CI full-time (during waking hours) for 13 months post-activation
* Is able to speak and read American English
* Uses oral/aural communication as primary communication modality
Exclusion Criteria:
* Intra-cochlear electrodes known to be open or short-circuits
* Partially-inserted CI with fewer than 10 intra-cochlear electrodes
* Any concomitant condition(s) that may affect performance on speech and music test battery (e.g., cognitive impairment)
* Atypical cochlear anatomy (e.g., fewer than 2 turns of the cochlea)
* Pregnancy (a contraindication for CT scan)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in score on the Consonant-Nucleus-Consonant (CNC) Test between chronic use of the CT-based program (~12 months post-activation) and chronic use of the clinical default program (~1 month post-switchover)