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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
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