Investigation of Automatic Technologies for Children with Hearing Loss
Official title: Investigation of Sky Automatic Technologies in Pediatrics
Run by Assistance Publique - Hôpitaux de Paris · NCT06400992 · Data updated 2026-11-12
This study tests a new technology to see if it helps children with hearing loss understand speech better in noisy places like classrooms and playgrounds.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 16 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | December 11, 2024 |
| Main results expected | December 11, 2026 |
| Study ends | June 2027 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT06400992 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 to 16 who use spoken French and have specific cochlear implants or hearing aids.
✕Probably not a fit
Patients with severe neurological, cognitive, psychiatric, or developmental disabilities, or those whose families do not understand French, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research evaluates the effectiveness of the AutoSense Sky OS 3.0 technology in improving speech recognition in noisy environments for children with hearing loss. The study compares different sound processing conditions, including the AS Target setting, to determine which provides the best listening experience in challenging auditory situations. Participants will include children aged 6 to 16 who primarily communicate in spoken French and use specific cochlear implants or hearing aids. The study aims to enhance auditory processing and communication abilities in everyday settings like classrooms and playgrounds.
Why it matters
Potential benefit: If successful, this study could significantly improve the ability of children with hearing loss to understand speech in noisy environments, enhancing their communication skills and overall quality of life.
How similar studies have gone: Other studies have shown success with similar auditory processing technologies, indicating a promising approach for improving speech recognition in children with hearing loss.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale") at the Necker-Enfants Malades hospital (AP-HP).
Paris, France Recruiting
Study contacts
- Study coordinator: Nathalie LOUNDON, MD, PhD
- Email: natalie.loundon@aphp.fr
- Phone: 01 71 39 67 82
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.