Electrophysiological-based Estimation of Cochlear Implant Fitting (ENPICME)

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Civil Hospices of Lyon

Status

Completed

Conditions

Cochlear Implants

Treatments

Other: Electrophysiological and psychoacoustic tests

Study type

Interventional

Funder types

Other

Identifiers

NCT02748915
69HCL15_0309

Details and patient eligibility

About

The primary objective of this research is to evaluate the relationships between multiple data from cochlear implant (CI) adult users to and to estimate predictive models of their fitting parameters. In a group of patients, the Electrically-evoked Compound Action Potentials (ECAP) will be collected intra-operatively and the correlation with demographic data (deafness duration, age deafness onset, etiology, duration of cochlear implant use of CI), auditory performances and subjective measures used for implant fitting (hearing threshold and most comfortable level) will be calculated. In a second group of experienced users (more than 9months of use of their CI), ECAP and Electrically-evoked Auditory Brainstem Response (EABR) will be collected after 9 months of CI experience and after 12 months or more of use. Correlation analyzes with demographic data, performance and fitting parameters will be performed as well. Statistical predictive models for both fitting at the activation or in experienced users should be developed according to the correlation analysis. The secondary objective is to evaluate the effects of simultaneous stimulation on hearing performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and compared in the different conditions.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Good general health status including no neuropsychological diseases affecting intellectual capacities
  • Users of cochlear implant or electro-acoustic stimulation devices
  • Normal otoscopy
  • No excessive sound exposure within 48h before the measure

Exclusion criteria

  • For women, possibility of pregnancy (absence of effective contraception or confirmed menopause);
  • Concomitant use of ototoxic or psychotropic treatment with anxiolytic and / or antipsychotic

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 3 patient groups

Patients using cochlear implants
Experimental group
Description:
All patients using cochlear implants included in the study will take electrophysiological and psychoacoustic tests to measure auditive parameters regarding the study objectives : ECAP, EABR, speech recognition and MCL.
Treatment:
Other: Electrophysiological and psychoacoustic tests
Patients using EAS device
Experimental group
Description:
Patients using EAS device for more than 11 months will take electrophysiological and psychoacoustic tests with the implant functioning only with electrical pulses or in bimodal mode to measure ECAP, EABR, speech recognition and MCL ; this will allow to perform bimodal comparison.
Treatment:
Other: Electrophysiological and psychoacoustic tests
Patients with bilateral cochlear implant
Experimental group
Description:
Patients with bilateral cochlear implant for more than 11 months will take electrophysiological and psychoacoustic tests to measure ECAP, EABR, speech recognition, and MCL. The binaural interaction component will also be measured ; this will allow to perform binaural comparison.
Treatment:
Other: Electrophysiological and psychoacoustic tests

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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