Clinical Evaluation of Frequency Allocation for Bimodal CI Users (NCT06663917) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Evaluation of Frequency Allocation for Bimodal CI Users
United States13 participantsStarted 2024-10-06
Plain-language summary
This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.
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
. Age 18 or older
. Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
. Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear
. Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
. Standard FAT use for all programs prior to study participation
. No known anatomical abnormalities in either ear
. English speaking
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
Sound Quality Questionnaire Score while using standard 188 Hz FAT
Timeframe: Baseline
2
Sound Quality Questionnaire Score while using experimental 438 Hz FAT
. Non-English speaking. Participants that are Non-English speaking are excluded from this study due to the use of speech testing materials that are validated in the English language. Additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages.
. Cognitively impaired
. Non-consistent device usage
. Greater than 70 dB hearing level pure tone average in the contralateral ear
. Normal hearing or mild hearing loss in the contralateral ear
. Non-standard FAT programs
. Use of any frequency transposition programming in hearing aid.
8
CNC word list score while using experimental 438 Hz FAT