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Completed

NCT Number: NCT02748915

Electrophysiological-based Estimation of Cochlear Implant Fitting

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.

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Key information

Conditions

Cochlear Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edouard Herriot - Service ORL Pavillon U

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrophysiological and psychoacoustic tests

Other

Primary outcomes

  1. ECAP threshold

    Time frame: from 11 months after cochlear implant activation

    ECAP amplitude growth function (AGF) will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP thresholds (in current unit) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to ECAP AGF recorded in clinical routine/during control visit before these 11 months that includes intra-operative records when available.

    The ECAP threshold recorded with and without acoustic stimulations will be compared in patients using EAS devices.

Secondary outcomes

  1. ECAP threshold

    Time frame: 9 months after cochlear implant activation

    ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. ECAP thresholds (in current unit) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.

  2. ECAP maximal amplitude

    Time frame: from 11 months after cochlear implant activation

    ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP maximal amplitudes (in µV) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to ECAP AGF recorded in clinical routine/during control visit before these 11 months that includes intra-operative records when available.

    The ECAP amplitude recorded with and without acoustic stimulations will be compared in patients using EAS devices.

  3. ECAP maximal amplitude

    Time frame: 9 months after cochlear implant activation

    ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. ECAP maximal amplitudes (in µV) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.

  4. ECAP latency

    Time frame: from 11 months after cochlear implant activation

    ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP latencies (in µs) of the ECAP recorded with the highest stimulation level will be determine , compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to ECAP AGF recorded in clinical routine/during control visit before these 11 months that includes intra-operative records when available.

    The ECAP latencies recorded with and without acoustic stimulations will be compared in patients using EAS devices.

  5. ECAP latency

    Time frame: 9 months after cochlear implant activation

    ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. ECAP latencies (in µs) of the ECAP recorded with the highest stimulation level will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.

  6. ECAP AGF slope

    Time frame: from 11 months after cochlear implant activation

    ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP AGF slopes (µV/qu) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to ECAP AGF recorded in clinical routine/during control visit before these 11 months that includes intra-operative records when available.

    The ECAP AGF slopes recorded with and without acoustic stimulations will be compared in patients using EAS devices.

  7. ECAP AGF slope

    Time frame: 9 months after cochlear implant activation

    ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. ECAP AGF slopes (µV/qu) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.

  8. EABR wave V maximal amplitude

    Time frame: from 11 months after cochlear implant activation

    EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. EABR wave V maximal amplitudes (µV) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to EABR AGF recorded in clinical routine/during control visit before these 11 months.

  9. EABR wave V maximal amplitude

    Time frame: 9 months after cochlear implant activation

    EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. EABR wave V maximal amplitudes (µV) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.

  10. EABR wave V latency

    Time frame: from 11 months after cochlear implant activation

    EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. EABR wave V latencies (ms) recorded with the highest stimulation level will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to EABR AGF recorded in clinical routine/during control visit before these 11 months.

  11. EABR wave V latency

    Time frame: 9 months after cochlear implant activation

    EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. EABR wave V latencies (ms) recorded with the highest stimulation level will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.

  12. EABR wave V threshold

    Time frame: from 11 months after cochlear implant activation

    EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. EABR wave V thresholds (current unit) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to EABR AGF recorded in clinical routine/during control visit before these 11 months.

  13. EABR wave V threshold

    Time frame: 9 months after cochlear implant activation

    EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. EABR wave V thresholds (current unit) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.

  14. EABR wave V AGF slope

    Time frame: from 11 months after cochlear implant activation

    EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. EABR wave V AGF slopes (µV/qu) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to EABR AGF recorded in clinical routine/during control visit before these 11 months.

  15. EABR wave V AGF slope

    Time frame: 9 months after cochlear implant activation

    EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. EABR wave V AGF slopes (µV/qu) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.

  16. EABR binaural interaction component (BIC)

    Time frame: from 11 months after cochlear implant activation

    In bilaterally implanted patients using both of their implants for more than 11 months, EABR BIC will be recorded with a reference electrode of either the older implant or the one associated with the best hearing performances and all the electrodes of the second implant. EABR BIC amplitude (µV) will be determined, compared according to the electrode pairing and correlation tests with the other measures will be performed.

  17. Most Comfort Level (MCL)

    Time frame: from 11 months after cochlear implant activation

    The MCL (current unit) will be evaluated for each electrode/cochlear site tested during the same recording session than the ECAP threshold evaluated after 11 months. These subjective limits will be compared according to the stimulation sites and correlated to ECAP and/or EABR characteristics.

  18. Most Comfort Level (MCL)

    Time frame: 9 months after implant cochlear implant activation

    The MCL (current unit) will be evaluated for each electrode/cochlear site tested during the same recording session than the ECAP threshold evaluated at 9 months. These subjective limits will be compared according to the stimulation sites and correlated to ECAP and/or EABR characteristics.

  19. Speech recognition score

    Time frame: from 11 months after implant cochlear implant activation

    The percentage of speech recognition will be measured at 60 decibels (dB) in open space with implant(s) well fitted during the same recording session than the ECAP threshold evaluated after 11 months. This performance level will be correlated to the ECAP and/or EABR characteristics. In the bimodal and binaural groups, performances will be compared between hearing conditions (monaural = 1 implant vs. bimodal or binaural hearing).

    During these audiometry tests, the recognition score will be also measured at 40 and 50 dB and a pure tone audiometry will be performed.

  20. Speech recognition score

    Time frame: 9 months after implant cochlear implant activation

    The percentage of speech recognition will be measured at 60 dB in open space with implant(s) well fitted during the same recording session than the ECAP threshold evaluated at 9 months. This performance level will be correlated to the ECAP and/or EABR characteristics.

    During these audiometry tests, the recognition score will be also measured at 40 and 50 dB and a pure tone audiometry will be performed.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Estimation of Perceptual Levels Used in Cochlear Implant Fitting Based on Electrophysiological Measures

Acronym: ENPICME

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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