NCT06400992 Investigation of Sky Automatic Technologies in Pediatrics
| NCT ID | NCT06400992 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-11 |
| Primary Completion | 2026-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-12-11 with a primary completion date of 2026-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Nathalie LOUNDON, MD,PhD
STUDY DIRECTOR
APHP
Frequently Asked Questions
Who can join the NCT06400992 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 16 Years, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06400992 currently recruiting?
Yes, NCT06400992 is actively recruiting participants. Contact the research team at natalie.loundon@aphp.fr for enrollment information.
Where is the NCT06400992 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06400992 clinical trial?
NCT06400992 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Nathalie LOUNDON, MD,PhD at APHP. The trial plans to enroll 20 participants.