Actively Recruiting

Age: 8Years - 17Years
All Genders
NCT06051006

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-12

30

Participants Needed

1

Research Sites

108 weeks

Total Duration

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Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (= C-Subjective). Currently, to define this C-Subjective level, patients are presented with a loudness scale and must indicate whether the sound stimulus, sent via the implant, is soft, comfortable, or loud. The lower and upper stimulation levels must be determined for each electrode in order to program the implant. For many patients this can be difficult due to a lack of auditory experience and confusion between the sensation of sound intensity (weak or loud) and frequency (low or high). A less commonly used but more objective approach to programming upper stimulation levels involves the use of the electrical stapedial reflex threshold (eSRTs) value. eSRTs are a promising measure, given the demonstrated correlation between the threshold that generates a stapedial reflex and the C-subjective level. Furthermore, eSRTs can be recorded in the majority of patients, and can typically be evoked at a comfortable stimulation level i.e. inferior to the uncomfortable level. The main objective of this study is investigate the link between subjective comfort levels (C-subjective levels) and the eSRT.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 8 to 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
  • Have information and non-opposition of holders of parental authority and minor patients to participate in the study
Not Eligible

You will not qualify if you...

  • Have a severe neurological pathology before inclusion (identified by MRI or neuro-pediatric assessment)
  • Have cognitive or psychiatric impairment or severe developmental delay at inclusion
  • Belong to a family that does not understand oral French
  • Are patients under AME (State Medical Aid)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Necker-Enfants Malades

Paris, France, 75015

Actively Recruiting

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Research Team

N

Nara Vaez-Leppin

CONTACT

H

Hélène Morel

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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