Investigation of Sky Automatic Technologies in Pediatrics (NCT06400992) | Clinical Trial Compass
RecruitingNot Applicable
Investigation of Sky Automatic Technologies in Pediatrics
France20 participantsStarted 2024-12-11
Plain-language summary
The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition, followed by the AS Clinic condition, and the Omni condition will be the least favourable for speech in noise performance.
Who can participate
Age range
6 Years – 16 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:
* Be between 6 and 16 years of age at the time of inclusion
* Use spoken French as their primary mode of communication
* Ability to perform the Simplified French Matrix test in Noise
* Bimodal group: use the Sky CI processor or be eligible for a Sky CI processor upgrade on one side and use a contralateral hearing aid
* Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors
* Obtain signed consent from legal guardian(s)
* Be enrolled in a health insurance plan or eligible for coverage
Exclusion Criteria:
* Severe neurological pathology identified prior to inclusion identified by MRI + /- neuro-pediatric workup
* Severe cognitive, psychiatric, or developmental disabilities identified prior to inclusion
* Family does not understand French
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.