Measuring electrical stapedial reflex thresholds for cochlear implant programming
Official title: The Value of Electrical Stapedial Reflex Thresholds (eSRTs) in Determining Upper Stimulation Levels in Cochlear Implant Maps
Run by Assistance Publique - Hôpitaux de Paris · NCT06051006 · Data updated 2026-11-12
This study is testing if measuring electrical responses in the ear can help improve cochlear implant settings for children with severe hearing loss to make their listening experience better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 8 Years to 17 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | December 7, 2023 |
| Main results expected | January 7, 2026 |
| Study ends | January 7, 2026 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT06051006 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 8-17 years who have had cochlear implants for at least one year and primarily communicate in oral French.
✕Probably not a fit
Patients with severe neurological pathologies, cognitive impairments, or those who do not understand oral 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 observational study aims to improve cochlear implant programming for children with profound hearing loss by utilizing electrical stapedial reflex thresholds (eSRTs) as an objective measure. The study will assess the correlation between eSRTs and subjective comfort levels in cochlear implant users aged 8-17 years. Participants will undergo various assessments, including eSRT and electric compound action potential (ECAP) measurements, to determine optimal stimulation levels for their cochlear implants. The goal is to enhance the accuracy of programming and improve auditory experiences for these patients.
Why it matters
Potential benefit: If successful, this approach could lead to more effective cochlear implant programming, resulting in improved hearing outcomes for children with profound hearing loss.
How similar studies have gone: While some studies have explored objective measures in cochlear implant programming, the use of eSRTs specifically is less common and may represent a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between the ages of 8-17 years at the time of inclusion with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades * Use oral French as the main mode of communication * Have a tonal threshold with the cochlear implant of 40 dB or more * Have a normal tympanogram * Have a voice threshold of less than 70% at 30dB HL * Information and non-opposition of holders of parental authority and minor patients to participate in the study Exclusion Criteria: * Present a severe neurological pathology before inclusion (which can be identified by an MRI +/- a neuro-pediatric assessment) * Present, on inclusion, a cognitive or psychiatric impairment or severe developmental delay * Be part of a family that does not understand oral French * Patients under AME (State Medical Aid)
Where it's running
-
Hôpital Necker-Enfants Malades
Paris, France Recruiting
Study contacts
- Principal investigator: Nara Vaez-Leppin — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Nara Vaez-Leppin
- Email: nara.vaez-leppin@aphp.fr
- Phone: 0187892914
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing a new way to help cochlear implant users hear music and speech better by improving how they perceive sound details that are usually missed.
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Observational registry for cochlear implant patients in the Middle East
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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.