Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation (NCT07371299) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation
60 participantsStarted 2026-01-15
Plain-language summary
Cochlear implants have been used for several decades, with major technological advances. However, adjustment can be difficult for patients who have to get used to a new sound that is electrical rather than acoustic. In general, adjustment is based on the patient's responses: the patient must inform the technician of their sensations in order to determine the sound level that is comfortable for them (MCL: maximum comfortable level).
The adjustment therefore depends on a subjective assessment. The aim of the adjustments is to make the sound pleasant while increasing the stimulation level to the maximum tolerated level in order to achieve good listening dynamics. Objective indicators would therefore be useful in improving the accuracy of the adjustments. The objective measurements that can be taken are:
* Electrical compound action potentials (eCAP)
* Electrical auditory brainstem response (eABR)
* Electrical stapedius reflex threshold (eSRT).
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:
Incident case cohort:
* Age ≥ 18 years (18 years or older)
* Scheduled for first-time unilateral cochlear implantation within the next 3 months
* Informed about the study and did not object (non-opposition)
Cross-sectional sample of prevalent cases:
* Age ≥ 18 years (18 years or older)
* Underwent unilateral cochlear implantation more than 1 year ago
* Has used the implant for more than 1 year (interval between implantation surgery and study inclusion \> 1 year)
* Informed about the study and did not object (non-opposition)
Exclusion Criteria:
Exclusion Criteria - applies to both the incident case cohort and the cross-sectional sample of prevalent cases:
* Prior middle or inner ear surgery
* Cognitive impairment or insufficient comprehension of French that would prevent understanding of study procedures or accurate measurement of comfort thresholds during programming
* Peripheral facial palsy
* Bilateral cochlear implantation
* Patient under legal guardianship/court-ordered protection
Additional exclusion - cross-sectional sample of prevalent cases only:
\- More than half of the electrodes not inserted (i.e., \<50% electrode insertion)
Secondary exclusion criteria - Incident case cohort:
* More than half of the electrodes not inserted (\<50% electrode insertion)
* Postoperative peripheral facial nerve palsy following the implantation surgery
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
The MCL threshold, the objective response threshold (eSRT), the eSRT response