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Search / Trial NCT06051006

The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 18, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Profound Hearing Loss Cochlear Implants Cochlear Implant Programming Stapedial Reflex

ClinConnect Summary

This clinical trial is studying how to better program cochlear implants for children with profound hearing loss. Specifically, it looks at a method called electrical stapedial reflex thresholds (eSRTs) to see if it can help determine the comfort levels of sound for patients. This is important because many young patients struggle to communicate how loud or soft sounds are for them, which can make it hard to set up their implants correctly. The goal is to find a reliable way to connect these comfort levels with eSRT measurements to improve the fitting of cochlear implants.

To participate in this study, children aged 8 to 17 who have had a cochlear implant for at least one year and use oral French for communication may be eligible. They need to meet specific hearing and health criteria, such as having a certain level of sound perception and a normal ear test. Participants will undergo assessments that help link their personal comfort with sound to the eSRT measurements. It's a great opportunity to contribute to research that could lead to better hearing experiences for young people with cochlear implants.

Gender

ALL

Eligibility 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)

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Melissa MacAskill

Study Director

Assistance Publique - Hôpitaux de Paris

Nara Vaez-Leppin

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported